Careers

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

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 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

Bioassay Development/QC is seeking for a Associate Scientist/ Scientist in the Bioassay group with experience in perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, as well as release testing of the Company’s therapeutic drug substance and drug products.

Key Responsibilities:

• Develop and qualify cell-based bioassay/potency assays, characterization assays, establish assay acceptance criteria for product characterization, lot release and stability testing applying appropriate statistical tools and comply with regulatory guidelines
• Provide testing support for the in-house manufacture of drug substance and drug product
• Basic math and software skills (MS Excel, Word, PowerPoint, Graph pad prism, SofmaxPro)
• Oversees the reagent inventory, reagent preparation, material ordering for the lab.
• Good interpersonal skills, the ability to work individually or as part of a team, and strong problem-solving capabilities. Have strong oral and written communication skills.
• Transfer of methods within the in-house QC department.
• Experience working in a regulated GMP environment is highly desirable
• Process data and present findings at regular team meetings
• Write SOPs, technical reports
• Document operating procedures for technology transfer and work with CROs/CMOs to implement methods in a GMP environment
• In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines
• Compliant with GxP, keep good lab notebook and experiment records.

Preferred Experience/Education:

BS, MS, PhD degree or a related discipline in Cell biology, Biochemistry with minimum 2+ years of experience in biotech or pharma industry.

Knowledge, Skills and Abilities:

• In depth knowledge of understanding the mechanism of action (MOA) of biologics and experience in design, and development of mechanism of action (MoA) reflective bioassays using appropriate technologies, such as cell based, ELISA and enzymatic assays experience is required
• Experience and knowledge of QC and GMP regulations is essential.
• Prior experience in cell culture, cell-based assay is required.
• Good understanding of statistical methods/tools for data analysis is strong plus.
• Team player, good interpersonal and organizational skills.
• Strong written and verbal communication skill
• Time management skills and ability to meet deadlines

Supplementary Skills:

• Additional techniques: qPCR, ELISA, binding assay, FACS
• Experience in GLP or GMP environment
• Management of external CROs/CMOs 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

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 Associate Scientist to support efforts in the discovery and development of novel, oral biological therapeutics to treat severe autoimmune, metabolic and inflammatory diseases. The successful candidate will be responsible for the design and execution of laboratory experiments aimed at characterizing novel therapeutics and developing biomarker assays to support clinical trials. Expertise in common immunology and molecular biology lab methodologies is required.

Key Responsibilities:

• Design and perform laboratory experiments to support biomarker discovery and assay development
• Generate, analyze, and summarize data from studies for inflammatory disease programs.
• Work independently as needed, as well as collaboratively with colleagues within and across functional areas
• Author nonclinical pharmacology reports and present in group / project team meetings

Preferred Experience/Education:

• Applicants must have a B.S. / M.S. in a science-related discipline and at least 10 years of relevant    experience, preferably in industry and drug development.
• Depth of knowledge and experience in immunology and molecular biology with applications towards cellular assay development. Direct experience in the investigation of pathways or interventional targets related to mucosal immunology and inflammatory bowel disease is optimal. 

Knowledge, Skills and Abilities:

• The successful candidate must have demonstrated proficiency in laboratory techniques in the area of immunology and molecular biology. Experience with most or all of the following is required: Flow cytometry, qPCR, ELISA and/or MSD, western blotting, cell culture, cloning/CRISPR
• Demonstrated excellence in designing and executing plate-based cellular assays
• Excellent data analysis, critical thinking, and communication skills (both written and verbal) and interpersonal skills are required. Must be able to work independently and have strong organizational and planning skills.
• Ability to use Excel, GraphPad Prism and FlowJo to analyze experimental results and generate data figures

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:

This position will support regulatory activities related to assigned company products, including but not limited to collecting and summarizing regulatory intelligence, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality. This position will participate in the compilation and production of various regulatory submissions with a focus on nonclinical/clinical aspects according to timelines and in compliance with established submission standards, including eCTD requirements. Responsible to ensure all RA deliverables of moderate complexity associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines.

Key Responsibilities:

• In conjunction with Regulatory Affairs department leadership, ensure optimal acceptable regulatory strategies for worldwide compliance and submissions
• Provide regulatory guidance to cross-functional teams for assigned projects and manage the preparation of INDs and CTAs in accordance with agreed timeframes
• Manage regulatory projects and closely collaborate with Clinical, Nonclinical/Translational, other scientific and technical departments and external vendors to coordinate and implement submission strategy
• Works with technical and medical writing to manage document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
• Lead preparations for, and participate in, meetings with regulatory agencies
• Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
• Provide review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
• Review clinical protocols to ensure collection of data needed for regulatory submissions

Preferred Education/Experience:

• Minimum BA/BS degree, and / or equivalent experience in a health science field. Advanced degree desirable.
• Minimum 4 years pharmaceutical industry experience, 3 years regulatory experience with increasing responsibility.
• Broad understanding of domestic and international regulations, processes and issues in drug/biologics development.
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
• Experience in the preparation and submission of regulatory documents in support of INDs, global CTAs preferred
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat

Knowledge, Skills and Abilities:

• Capable of critically reviewing complex technical documents and influencing colleagues across functions
•  Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment internally and externally
• Willingness to think outside of the box and adapt best practices and ability to adapt in a constantly evolving environment
• Self-motivated with a strong sense of ownership in areas of responsibility
• High degree of professionalism, ethics and integrity
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
• History of successful interactions with global regulatory authorities
• Able to perform independently and think analytically and creatively to solve problems
• Ability to be a true team player working toward common goals
• Willing to travel domestically and internationally up to 15%

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