Careers

The Associate/Senior Associate will support the Clinical Trial Managers to ensure the success of current and future clinical trials at AMT. The CTS will work with the CTM to assist with the planning and implementation of multiple studies within a clinical development program. The position will also work closely with other cross-functional representatives including Regulatory, Clinical Development, Project Management, and QA to ensure successful completion of all clinical activities/project deliverables within the required time frame. The position will also support oversight of the CRO and other third-party vendors on the assigned study. This individual will report to a Clinical Trial Manager.

Key Responsibilities:

• Assist CTMs with activities related to study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment.
• Assist with tracking, reviewing, distribution, and storage of key internal and external documents such as investigator brochures, protocols, interim safety reports, and site/subject material, through the course of the study.

• Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor metrics, and Enrollment metrics.
• Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met and study documents are delivered to the Sponsor in a timely manner.
• Track study wide clinical supply inventory, vendor supplies at sites and management of study samples.

• Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out and responding to TMF related inquiries.
• Maintains and ensures all documentation is in a state of audit-readiness.
• Utilize project management tools (e.g. Outlook, Word, PowerPoint, Timelines, Excel) in order to plan and execute effective meetings with appropriate materials and balance scope and schedule for each trial.
• Creates meeting agenda/minute templates and provides drafts of meeting minutes.
• Support clinical team efforts to track and contribute to regulatory submissions in the US and globally by coordinating and tracking approvals of clinical documents.
• Ensures Good Clinical Practices are followed, ensures protocol deviations are properly recorded, SOPs are maintained and routinely updated, and CRO/site audits are tracked.
• Coordinate collection, tracking, and maintenance of updated site regulatory documentation (i.e. FDFs, 1572s, CVs, IRB approvals, etc.).
• Develop working knowledge of company standard operating procedures (SOPs) and familiarity with FDA and global regulations related to clinical studies.
• Participates in organizing investigator meetings including venue selection, invitations, agenda, and materials distribution.
• Communicates effectively with members of the AMT and vendor project teams.
• Other tasks or responsibilities as assigned.

Preferred Education/Experience:

• A Bachelor’s or Associate’s degree is required. A BA or BS in biological sciences, nursing, or related field is preferred. Prior CTA experience and exposure to clinical trial operations is preferred.

Knowledge, Skills and Abilities:

• Knowledge and/or experience of operational aspects of all stages of clinical studies, knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Familiar with using eTMF, EDC, IRT, CTMS, SharePoint and other vendors systems/portals.
• Thrives in a dynamic start‐up environment with busy, high performing colleagues; flexibility to wear multiple hats as needed.
• Ability to learn quickly and effectively using newly acquired skills, ability to use time efficiently, multi-task, prioritize, track projects, and follow-through on-time with assigned tasks with exceptional attention to detail.
• Excellent organizational and communication skills: Is able to listen and follow instructions; asks questions or clarifications as needed; is transparent and able to communicate clearly and effectively.
• Demonstrates accuracy, thoroughness, and thoughtfulness; is able to assess strengths and development areas; Provides quality deliverables and strives to continuously build knowledge and skills.
• Strong work ethic; A motivated, positive minded individual who is proactive, flexible and solution oriented to address changing program needs in real time.
• Team player who is collaborative, accountable, self-aware; works well in a team environment but can also work independently without significant oversight.
• Contributes to building a positive team spirit and company culture; Supports everyone’s efforts to succeed; Shares expertise with others.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Perform and appropriately document the calibration, qualification, troubleshooting, and repair of a variety of analytical, manufacturing, and facility equipment. Assist in the development of in-house qualification, calibration and maintenance procedures; and provide knowledgeable customer service to equipment owners.  Responsible for the execution of the metrology functions required to support the facility and process equipment. Perform calibrations and schedule vendor calibrations of instrumentation and equipment. Repair and troubleshoot electronics and instrumentation as well as other equipment as able.  Design and prepare all protocols and reports related to diverse validation activities. Focus on Cleaning, Equipment, Utilities, and Software Validation.

Key Responsibilities:

Calibration:

• Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards
• Design, develop, implement and maintain calibration processes and procedures for new and existing equipment and instrumentation and train key personnel on proper use.
• Coordinate and perform calibration of instrumentation necessary for maintaining production equipment, laboratory equipment and other auxiliary measurement systems.
• Perform routine calibrations and requalifications as required, as well as non-routine calibrations and requalifications as business needs dictate
• Maintains detailed calibration records.
• Maintain clear, concise, and compliant records of all work performed for the purpose of documenting the control of all equipment and utilities
• Review calibration documents for accuracy and completeness
• Execute and report temperature mapping studies of controlled storage equipment
• Write and execute equipment qualification protocols for laboratory, manufacturing, and facility equipment and report protocol execution results
• Clearly communicate calibration/requalification schedules and equipment status with Equipment Owners
• Maintain metrology standards in working condition and ensure that they are used within their calibration intervals
• Schedule and escort contract calibration and validation providers, and review their documents for accuracy
• Assist in gathering and shipping equipment that requires off-site calibration.
• Write and/or review calibration procedures, calibration specifications and calibration worksheets.
• Provide guidance to Equipment Owners regarding the selection and maintenance of equipment.
• Move and install equipment, when required
• Perform both scheduled and unscheduled maintenance on laboratory, facility, and manufacturing equipment, when required
• Assist in calibration and validation document management, including data entry and filing
• Apply engineering principles to generate solutions to problems.
• Assist in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems.

Validation:

• Apply cGMP guidelines to all aspects of validation.
• Established procedures with some supervision.
• Write, execute, and approve validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
• Write summary reports, following good documentation practices.
• Use Kaye Validator or other dataloggers to perform mapping studies.
• Analyze statistical data to verify acceptable criteria.
• Develop testing strategies and rationale for equipment/systems.
• Provide technical support/troubleshooting for process and equipment issues.
• Maintain close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation.
• Investigate/resolve deviations associated with validation studies.
• Assist with commissioning, FATs, and SATs.
• Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
• Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.
• Critically review complex data to ensure completeness, accuracy, and compliance.
• Write and revise SOPs and Master Plans biennially or as part of process improvements.
• Assist in cleaning validation activities and plans associated with projects at the site.

Preferred Experience/Education:

• Bachelor’s degree in engineering / related discipline with 2-5 years’ experience or High School diploma with 5-10 years’ experience
• Job experience in a pharmaceutical manufacturing environment required.
  Experience in industrial/pharmaceutical metrology setting preferred

Knowledge, Skills and Abilities:

• Detailed knowledge of calibration procedures and basic knowledge of programmable logic controllers is preferred
• Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and cGMP manufacturing is very desirable.
• Strong organization and communication skills; high level of personal/departmental accountability and responsibility.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to use computer programs such as Microsoft Office, EDMS, and SAP.
• Ability to work in a team environment.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision and guidance.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are currently seeking a Associate Scientist to join our team. This individual will be motivated and thrives as part of cross-functional team within Applied Molecular Transport. This an exciting opportunity for an individual motivated to see his work directly impact the development of our lead molecule. The successful candidate will be a bench research associate and key member of the biological sciences. The candidate will help to advance programs from discovery to IND/CTA filing.

Key Responsibilities:

• Develop and perform in vivo, ex vivo, and in vitro studies.
• Assist in developing and performing PK/PD assays for multiple animal models.
• Generate reports and presentations for cross-functional team meetings.
• Actively participate in team meetings to discuss and review data.

Preferred Education/Experience:

• A Bachelor’s/Master’s degree or equivalent experience in pharmacology, physiology, biology, or relevant degree with at least 2 years of hands-on work experience in a biotech or pharma setting.
• Proficiency in designing and executing a variety of in vivo, ex vivo and in vitro studies.

Knowledge, Skills and Abilities:

• Passion to maintain current scientific knowledge focused on pharmacology, toxicology and molecular pharmacology.
• Comfortable at working independently and managing multiple projects in a fast-paced environment.
• Familiarity with animal model development across inflammatory and metabolic diseases.
• Proficiency in designing and executing in vivo PK/PD studies.
• Proficiency with various in vivo skills including dosing (IV, SC, IP, PO), bleeding and harvesting/processing of tissue is a must.
• Experience with ELISA, Western blotting, RT-qPCR, flow cytometry, microscopy and histology is required; experience with Meso Scale Discovery system is a plus.
• Working knowledge of PK/PD principles and software (e.g., WinNonlin, NONMEM, SimBiology, etc)
• Expertise in data analysis software: MS PowerPoint, MS Excel, MS Word and GraphPad Prism.
• The ability to be innovative and creatively solve problems.
• Outstanding written, verbal, and presentation skills are a must.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

The Scientist/Sr. Scientist position is within AMT’s analytical development group that is based at Tower Place, South San Francisco. In this role, the scientist will perform method development, qualification, and technology transfer for the release and stability testing of drug substance and drug products. The position will report to Director of Analytical Development and collaborate with cross-functional teams at AMT.

Key Responsibilities:

• Perform analytical method development for LC based assays such as SEC, IEX and reversed-phase HPLC, and other protein-based analysis (i.e. SDS-PAGE, CE-SDS, A280, etc.)
• Provide testing support for the in-house manufacture of drug substance and drug product.
• Execute stability studies to evaluate and characterize protein degradation during storage
• Process data and present findings at regular team meetings
• Document operating procedures for technology transfer and work to implement methods in a GMP environment
• Write technical reports

Preferred Experience/Education:

• BS, MS, PhD or equivalent degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences or a related discipline
• 1-5 years of experience in the biotech/pharmaceutical industry preferably in a regulated environment

 Knowledge, Skills and Abilities:

• Practical experience with protein chemistry, degradation and stabilization mechanisms
• Experience with HPLC, electrophoresis, UV-Vis spectroscopy and other analytical methods
• Interpersonal skills and ability to contribute to the success of a team
• Strong written and verbal communication skills
• Time management skills and ability to meet deadlines
• Experience with solid dosage form analysis (i.e. dissolution, assay, KF, etc.)

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

AMT is looking for an Upstream Manufacturing Associate to work in our GMP manufacturing facility to produce biopharmaceutical proteins. The primary focus of the Manufacturing Associate role will be work as part of a team to conduct GMP upstream manufacturing production assignments and tasks with high quality and timely output.

Primary Responsibilities

• Set-up and operation of single-use fermentation, cell processing, and separation equipment.
• Process monitoring and sampling, including performing routine sample analysis.
• Weigh out chemicals, prepare media, solutions, and buffers.
• Participation in daily operation and routine maintenance of process and analytical equipment.  Maintaining a clean and organized lab environment. Chemicals and consumables stocking, etc.
• Maintaining strict adherence to batch records, SOP’s, and safety guidelines designate for the manufacturing process.

Required Qualifications

• A Bachelor’s degree or equivalent experience in Chemical Engineering, Microbiology, Biochemistry, or related field.
• 0-2 years of experience in cGMP biologics manufacturing,
• Operation of basic lab equipment including pipettes, scales, and pH/conductivity meters, and incubators.
• Familiar with aseptic processing and sterile handling techniques.
• Excellent interpersonal and communication (oral and written) skills, documentation, organization, good record keeping.
• Strong technical competency in the scientific principles of fermentation, microbiology and basic chemistry.
• Attention to detail, safety and good laboratory practice.

Preferred Qualifications

• At least 2 years of hands-on lab experience with fermentation related processes.
• Experience with microbial fermentation and cell separation equipment including fermentors, centrifuges, and homogenizers.
• Ability to identify, challenge, and implement potential improvements to manufacturing processes.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

As a Senior Accountant for the Finance team, you will report to the Director, Accounting Operations and work closely with other Finance team members. You will be assisting with the balance sheet reconciliations, monthly/quarterly financial statement preparation and the preparation of audits. This also includes financial statements and various MD&A and footnote schedules, SOX internal controls, and various month-end close processes.

You will apply your existing accounting skills and knowledge, learn new skills, and play a key role in assisting the growth of the Finance department.

Key Responsibilities:

• Prepare monthly and quarterly journal entries and account reconciliations to ensure accurate reporting and ledger maintenance
• Support the requirement of the annual audit and quarterly reviews through preparation of audit schedules and other support requested by external auditors.
• Work cross functionally with various business owners as well as external consultants.
• Assist ad-hoc project as needs arise, system improvements, and other financial requests including but no limited to variance analysis and other fluctuation analysis.

Preferred Experience/Education:

• BS or BA in Accounting or related field
• 5+years of relevant experience from public accounting and/or industry
• Experience with manufacturing or inventory accounting, a plus

Knowledge, Skills and Abilities:

• Strong working knowledge of system processes, internal controls and US GAAP
• Detailed and results-oriented and able to stay self-motivated
• Excellent written and verbal communication and interpersonal skills
• Knowledge/Experience with NetSuite
• Audit experience with a big four accounting firm, a plus

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Applied Molecular Transport are looking for an experienced Fermentation Scientist to develop, optimize and scale-up upstream processes for the production of biopharmaceutical proteins.

Primary Responsibilities

• Design and execution of experiments to develop and optimize fermentation and primary recovery processes for the production of novel therapeutic proteins.
• Production of small amounts of biopharmaceutical protein for use in pre-clinical studies.
• Collaboration with various teams for the transfer of processes to manufacturing facility.

Required Skills

• Strong technical competency in the scientific principles of fermentation and microbiology.
• Extensive experience in the operation of lab scale fermentation equipment.
• Demonstrated experience of media and process development for fed-batch fermentation including the use of DOE techniques.
• Good working knowledge of E. coli expression systems and related processes.
• Experience with process monitoring and analysis using biological, biochemical, and analytical chemistry assay techniques.
• Competence in data analysis and presentation of experimental results.
• Understanding of regulatory requirements for the development and production of biopharmaceutical products.
• Excellent interpersonal and communication (oral and written) skills, documentation, organization, good record keeping, writing reports and SOPs.
• Attention to detail, safety and good laboratory practices.
• Experience in supervising and mentoring direct reports.

Required Experience

• A PhD degree or equivalent experience in Chemical Engineering or Microbiology or related field.
• At least 4 years of hands-on Industrial experience developing microbial fermentation processes.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

The Clinical Trial Manager/Senior Clinical Trials Manager will be responsible for the operational management and oversight of clinical trials within a clinical development program. The position will work closely with the Medical Monitor and other cross-functional representatives including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology and Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The position will also provide oversight of the CRO and other third-party vendors on the assigned study. This individual will report into the Head of Clinical Operations.

Key Responsibilities:

• Responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies. 
• Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision. 
• Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.   
• Actively provides operational direction and/or general supervision to direct reports
• Assist with training and mentoring of internal clinical operations staff. 
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines. 
• Manage CROs, vendors and consultants that are involved with the clinical trial and program. 
• Track and report on progress of study including site activation, patient enrollment, monitoring visits
• Perform clinical data review of data listings and summary tables, including query generation  
• Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
• Develop and maintain good working relationships with investigators and study staff
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
• Investigate queries, monitor discrepancies
• Manage investigational product (IP) accountability and reconciliation process
• Responsible for review or approval of IP release packages
• Negotiate and manage the budget and payments for investigative sites
• Develop CRA and third-party vendor training on protocols and practices 
• Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned. 
• Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work

Preferred Education/Experience:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is desired.

Knowledge, Skills and Abilities:

• Extensive experience managing clinical programs, CROs, budgets, and timelines required

• Proven experience in the oversight of the operational aspects of all stages of clinical studies
• Ability to organize and manage multiple priorities required
• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Proactive and positive management approach
• Maximum flexibility to adapt to changing program needs in real time
• Strong leadership skills and self-awareness
• Ability to build strong relationships with co-workers of various backgrounds and expertise

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

We are looking for an HR Specialist to join our growing team.  This is a very exciting time. This role can provide the right candidate a unique opportunity to contribute to the building /evolving of Applied Molecular Transport.   The HR Specialist responsibilities include- preparing compensation and benefits packages, involvement in full cycle recruitment and onboarding, and maintaining updated employee records. To be successful in this role, you should have a good understanding of full cycle recruiting and solid knowledge of labor legislation. Ultimately, this role will always foster a healthy workplace by ensuring our HR procedures run smoothly.

Key Responsibilities:

• Assists with recruitment process, including placing job postings and scheduling interviews.
• Maintain personnel files, conduct audits to ensure the files are accurate and complete.
• Maintain employee/compensation records.  Process Payroll Change Notices which document a change in the status of an employee through compensation, title, status, etc.
• Complete offer letters/agreements as directed.
• Complete termination/separation agreements as directed.
• Maintain New Employee Packets and Termination Packets.
• Maintain employee handbook and other corporate policies.
• Implement methods of improving issues in the Human Resources Department as needed.
• Under direction, prepare and review compensation and benefits packages.
• Create and provide reporting metrics and data including Compliance Reporting, headcount reporting, AAP/EEO/VETS reporting as well as any Ad Hoc reporting needed for internal and external clients.
• Maintain organizational charts and detailed job descriptions along with salary records.
• Process employees’ queries and respond in a timely manner.
• Support HR team in ensuring compliance to all Federal and State labor, wage and hour, and other laws and regulations with an eye for scaling and a mindset for efficiency.
• Handle ad hoc employee HR questions, as well as resolve or filter employee relations issues to the appropriate parties.
• Participates in projects for HR and/or business teams as needed

Preferred Experience/Education:

• BS in Human Resources or relevant field
• 2-4 years’ experience or MA / MS in human resources

Knowledge, Skills and Abilities:

• Compensation and Benefit experience and knowledge a plus
• Strong organizational, record-keeping and follow-up skills
•  Attention to detail is a must; strong analytical skills favored
•  Proficiency in MS Office applications, primarily Excel and Word.
•  Knowledge of Applicant Tracking Systems
•  Basic knowledge of Federal, State, and local HR regulations.
•  Familiarity with full cycle recruiting
•  Excellent verbal and written communication skills
•  Good problem-solving abilities
•  Ability to demonstrate good judgment and discretion.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

We are seeking a talented and dynamic scientist to help drive efforts in the discovery and development of novel, oral biological therapeutics to treat severe autoimmune, metabolic and inflammatory diseases.

The successful candidate will drive nonclinical programs aimed at identifying and characterizing novel therapeutics and will work in close collaboration with teams throughout the organization, including biology, platform sciences, CMC, regulatory affairs, and clinical development.

Key Responsibilities:

• He/she will support and represent projects across preclinical research and into early clinical development, acting as a leader or member of a multidisciplinary project team.
• As a leader in the organization, the successful candidate will successfully maintain alignment and excellent communications with key stakeholders internally, and ably represent AMT to external collaborators and in public presentations.
• Author nonclinical pharmacology reports and nonclinical pharmacology sections of regulatory documents
• Additional activities include managing and identifying key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities.

Preferred Experience/Education:

• Applicants must have a MS degree with at least 10 years or PhD with at least 4 years of relevant post graduate experience, preferably in industry.
• Demonstrated experience in target discovery, translational research, and drug development is strongly preferred. Direct experience in the investigation of pathways or interventional targets related to metabolic, inflammation and/or cancer is optimal.

Knowledge, Skills and Abilities:

• Excellent communication skills (both written and verbal) and interpersonal skills are required. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Preference will be given to candidates with a strong background and hands-on experience in cell biology and drug discovery using a variety of in vitro and in vivo pre-clinical models.
• The successful candidate must have demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
• Experience authoring of technical reports, drug discovery documents, and regulatory submissions desired
• Demonstrated scientific leadership, mentoring and organizational skills with respect to both managing direct reports as well as external collaborations and/or CROs.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

We are seeking a talented and dynamic scientist to help drive efforts in the discovery and development of novel, oral biological therapeutics to treat severe autoimmune, metabolic and inflammatory diseases.

The successful candidate will drive nonclinical programs aimed at identifying and characterizing novel therapeutics and will work in close collaboration with teams throughout the organization, including biology, platform sciences, CMC, regulatory affairs, and clinical development.

Key responsibilities:

• Lead cross-functional nonclinical teams to execute on development strategies to generate, analyze, and summarize data from studies for drug discovery programs
• As a leader in the organization, you will successfully maintain alignment and excellent communications with key stakeholders internally, and ably represent AMT to external collaborators and in public presentations.
• Author nonclinical pharmacology reports and nonclinical pharmacology sections of regulatory documents
• Additional activities include managing and identifying key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities.

Knowledge, Skills and Abilities

• Excellent communication skills (both written and verbal) and interpersonal skills are required. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• The successful candidate must have demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
• Previous project leadership in drug discovery preferred
• Experience authoring of technical reports, drug discovery documents, and regulatory submissions desired
• Demonstrated scientific leadership, mentoring and organizational skills with respect to both managing direct reports as well as external collaborations and/or CROs.

Preferred Education/Experience:

• Applicants must have a MS degree with at least 10 years or PhD with at least 4 years of relevant post graduate experience, preferably in industry.
• Demonstrated experience in target discovery, translational research, and drug development is strongly preferred. Direct experience in the investigation of pathways or interventional targets related to metabolic, inflammation and/or cancer is optimal.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

We are seeking a talented and dynamic scientist to lead efforts in the discovery and development of novel, oral biological therapeutics to treat severe autoimmune, metabolic and inflammatory diseases.

The successful candidate will responsible for the design and implementation of nonclinical programs aimed at identifying and characterizing novel therapeutics and will work in close collaboration with teams throughout the organization, including biology, platform sciences, CMC, regulatory affairs, and clinical development.

Key responsibilities:

• Lead cross-functional nonclinical teams to execute development strategies to generate, analyze, and summarize data from studies for inflammatory disease programs
• As a leader in the organization, you will successfully maintain alignment and excellent communications with key stakeholders internally, and ably represent AMT to external collaborators and in public presentations.
• Author nonclinical pharmacology reports and nonclinical pharmacology sections of regulatory documents
• Additional activities include managing and identifying key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities.

Knowledge, Skills and Abilities

• Excellent communication skills (both written and verbal) and interpersonal skills are required. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• The successful candidate must have demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
• Previous project leadership in drug discovery preferred
• Experience authoring of technical reports, drug discovery documents, and regulatory submissions desired
• Demonstrated scientific leadership, mentoring and organizational skills with respect to both managing direct reports as well as external collaborations and/or CROs.

Preferred Education/Experience:

• Applicants must have a PhD or equivalent degree and at least 6 years of relevant post graduate experience, preferably in industry.
• Demonstrated experience in target discovery, translational research, and drug development is strongly preferred. Direct experience in the investigation of pathways or interventional targets related to mucosal immunology and inflammatory bowel disease is optimal.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Applied Molecular Transport (AMT) is developing targeted oral biological therapeutics, with the patient-centric goal of expanding biological possibilities to enhance therapeutic outcomes and improve drug safety profiles.  Our technology platform is fueling a unique pipeline of first-in-class molecules to treat a wide range of diseases, including autoimmune, inflammation, cancer, metabolic and hepatologic disorders. Our products mimic the biology of microbial and other natural processes that modulate health and disease via mucosal immunology.

AMT is seeking a highly motived individual with GCP/GLP quality experience.  As the QA Specialist, you will interface with a diverse internal team across Clinical, Quality Assurance, and Regulatory.  This role requires the ability to effectively communicate with cross-functional teams, independently manage timelines, and continually strengthen external department relations. You will need to be organized and detail oriented with strong and effective written, verbal, mathematical, and interpersonal communication skills. This role will require you to have the ability to work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity. This role will also require the ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions.  Off-shift, weekend and overtime duties may be required as assigned by the manager of the employee.

Primary Responsibilities include, but are not limited to:

• Participate in the development, implementation, and maintenance of the company’s GCP quality management system and facilitate continuous improvement.
• Provide GCP QA oversight and support to internal staff and represent QA on project teams.
• Develop and implement audit plans and yearly GCP /GLP audit schedules.
• Schedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, animal testing sites, vendors, process, and system.
• Support internal and external GLP testing to ensure compliance with guidelines, SOPs, protocols, and industry standards.
• Conduct QA review of GLP methods, data and reports.
• Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
• Coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
• Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
• Schedule and/or deliver yearly GCP/GLP training for internal staff.
• Keep informed of current and new regulatory requirements and trends.
• Other duties as assigned

Required Experience and Qualifications

• BS degree in a scientific discipline
• Strong attention to detail
• 3+ years of direct experience within Quality in a GLP/GCP environment
• 2+ years of direct experience creating, revising, reviewing, and approving of controlled documentation
• Solid understanding of GCP, GLP and ICH requirements
• Knowledge of governmental regulatory guidelines, directives and regulations relating to the manufacturing of biologics
• Experience working effectively with cross-functional teams in a fast-paced, dynamic environment
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
• Internal/external audit experience
• Able to travel up to 20% of the time
• Experience using Adobe Acrobat Professional, MS WORD, Excel, PowerPoint
• Experience with MasterControl and Veeva Vault is a plus

Reports to:  Vice President Quality

Location: South San Francisco, California

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Applied Molecular Transport (AMT) is developing targeted oral biological therapeutics, with the patient-centric goal of expanding biological possibilities to enhance therapeutic outcomes and improve drug safety profiles.  Our technology platform is fueling a unique pipeline of first-in-class molecules to treat a wide range of diseases, including autoimmune, inflammation, cancer, metabolic and hepatologic disorders. Our products mimic the biology of microbial and other natural processes that modulate health and disease via mucosal immunology.

AMT is seeking a highly motived individual with quality review and disposition of raw materials and product batch record experience.  As the QA Specialist, you will interface with a diverse internal team across Materials Management, Manufacturing and Quality Control functions.  This role requires the ability to effectively communicate with cross-functional teams, independently manage timelines, and continually strengthen external department relations. You will need to be organized and detail oriented with strong and effective written, verbal, mathematical, and interpersonal communication skills. This role will require you to have the ability to work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity. This role will also require the ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions.  Off-shift, weekend and overtime duties may be required as assigned by the manager of the employee.

Primary Responsibilities include, but are not limited to:

• Performing product inspections and facility inspections
• Line Clearances
• General product observations
• Reviewing Master Batch Records, Executed Batch Records, Deviations, Out-of-Specification documentation
• Logging, monitoring and trending quality related data
• Quality on the floor, as per the manufacturing schedule
• Ensure all necessary documentation is prepared and coordinated between various departments (MFG/QC/MM)

Required Experience and Qualifications

• BS degree in a scientific discipline
• Strong attention to detail
• 3+ years of direct experience within Quality in a GLP/GCP/cGMP environment
• 2+ years of direct experience creating, revising, reviewing, and approving of controlled documentation
• Direct experience with MasterControl for document management, deviations, change control, CAPA and standalone forms
• Knowledge of governmental regulatory guidelines, directives and regulations relating to the manufacturing of biologics
• Cleanroom experience
• Experience working effectively with cross-functional teams in a fast-paced, dynamic environment
• Strong understanding of cold chain management
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
• Internal/external audit experience is preferred but not mandatory
• GMP raw materials/consumable Quality support for inventory management/investigation is preferred but not mandatory

Reports to:  Sr. Manager Quality

Location: South San Francisco, California

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Applied Molecular Transport is developing targeted oral biological therapeutics, with the overriding patient-centric goal of expanding biological possibilities to enhance therapeutic outcomes and improve drug safety profiles. 

Our technology platform is fueling a pipeline of first-in-class molecules to treat a wide range of diseases, including autoimmune, inflammation, cancer, metabolic and hepatologic disorders. Our products mimic the biology of microbial and other natural processes that modulate health and disease via mucosal immunology.

We are seeking a talented scientific professional to join the Pharmaceutical Science team to develop novel dosage forms to advance our innovative technology platform. This role is responsible for defining and implementing laboratory strategies for oral drug product innovation, formulation development and manufacturing support for our pipeline of biologic products. This position will support development teams to bring proprietary biopharmaceuticals through clinical development.

Primary Responsibilities

• Key role in developing formulations for AMT pipeline biologic products
• Evaluate novel biologic molecules and determine suitable formulation approach to meet pre-clinical and clinical requirements
• Design and conduct experiments to achieve stable, high-performing formulations
• Collaborate with analytical team for characterization and method development
• Support internal teams and CROs with materials and documentation for required studies
• Represent Pharmaceutical Science function on project teams and provide formulation input to overall development plans
• Formulation leadership role on external collaborations and internal projects
• Identify and select external partners to support formulation needs
• Support regulatory filings by contributing to drug product CMC sections.
• Support drug product development and tech transfer activities to contract manufacturing sites
• Prepare verbal presentations, technical memos and reports
• Recruit and supervise Research Associates, Scientists or other lab staff

Education/Experience

• PhD in chemistry/biochemistry/analytical/chemical engineering or related field
• 7+ years industry experience (or MS with 12+ years industry experience) in biopharmaceutical formulation development or related field

Knowledge, Skills and Abilities

The ideal candidate will have the following attributes and experience:

• Hands on experience and knowledge in biologics formulation development and characterization
• Good understanding and practical application of chromatographic and other analytical techniques for protein therapeutics
• Expertise in developing phase-appropriate formulations for protein therapeutics, including experience with US/EU regulatory and quality requirements
• Experience with CRO selection and relationship management
• Excellent written and verbal communication skills
• Team-oriented work style, with effective conflict-resolution and stake-holder management skills
• Flexible to changing priorities and timelines

Reports to:  Vice-President, Pharmaceutical Sciences

Location: South San Francisco, California

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Position Summary:

The Scientist/Sr. Scientist position is within AMT’s analytical development group that is based at Tower Place, South San Francisco. In this role, the scientist will perform method development, qualification, and technology transfer for the release and stability testing of drug substance and drug products. The position will report to Director of Analytical Development and collaborate with cross-functional teams at AMT.

Key Responsibilities:

• Perform analytical method development for LC based assays such as SEC, IEX and reversed-phase HPLC, and other protein-based analysis (i.e. SDS-PAGE, CE-SDS, A280, etc.)
• Provide testing support for the in-house manufacture of drug substance and drug product.
• Execute stability studies to evaluate and characterize protein degradation during storage
• Process data and present findings at regular team meetings
• Document operating procedures for technology transfer and work to implement methods in a GMP environment
• Write technical reports

Preferred Experience/Education:

• BS, MS, PhD or equivalent degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences or a related discipline
• 1-5 years of experience in the biotech/pharmaceutical industry preferably in a regulated environment

Knowledge, Skills and Abilities:

• Practical experience with protein chemistry, degradation and stabilization mechanisms
• Experience with HPLC, electrophoresis, UV-Vis spectroscopy and other analytical methods
• Interpersonal skills and ability to contribute to the success of a team
• Strong written and verbal communication skills
• Time management skills and ability to meet deadlines
• Experience with solid dosage form analysis (i.e. dissolution, assay, KF, etc.)

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets

Position summary:

We are seeking a talented and dynamic scientist to lead efforts in the discovery and development of novel, oral biological therapeutics to treat severe autoimmune, metabolic and inflammatory diseases. The successful candidate will responsible for the design and implementation of nonclinical programs aimed at identifying and characterizing novel therapeutics and will work in close collaboration with teams throughout the organization, including biology, protein sciences, CMC, regulatory affairs, and clinical development.

Key responsibilities:

• Lead cross-functional nonclinical teams to execute development strategies to generate, analyze, and summarize data from studies for inflammatory disease programs.
• As a leader in the organization, you will successfully maintain alignment and excellent communications with key stakeholders internally, and ably represent AMT to external collaborators and in public presentations.
• Author nonclinical pharmacology reports and nonclinical pharmacology sections of regulatory documents.
• Additional activities include managing and identifying key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities.

Preferred Education/Experience:

• Applicants must have a PhD or equivalent degree and at least 8 years of relevant post graduate experience, preferably in industry.
• Demonstrated experience in target discovery, translational research, and drug development is strongly preferred. Direct experience in the investigation of pathways or interventional targets related to mucosal immunology and inflammatory bowel disease is optimal.

Knowledge, Skills and Abilities

• Excellent communication skills (both written and verbal) and interpersonal skills are required. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• The successful candidate must have demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
• Previous project leadership in drug discovery preferred
• Experience authoring of technical reports, drug discovery documents, and regulatory submissions desired
• Demonstrated scientific leadership, mentoring and organizational skills with respect to both managing direct reports as well as external collaborations and/or CROs.

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets