Applied Molecular Transport (AMT) is currently growing its R&D organization to enable various aspects of its CMC and product development activities required to bring AMT technology-enabled biopharmaceuticals to clinical testing. AMT’s novel, proprietary technology platform allows for the efficient delivery of biopharmaceuticals across the intestinal epithelium; the critical step that has previously evaded the pharmaceutical industry in its efforts to identify commercially viable oral dosage forms for therapeutic peptides and proteins. AMT’s approach is based on solid scientific principles related to the biology of the GI tract. The company’s goal is to develop biopharmaceuticals that by their oral delivery will enable, or at the very least enhance, previously unappreciated biological outcomes for agents delivered by the oral-GI route.

Position Description

An immediate opening exists for a Sr. Scientist, Protein Formulation Development in the Pharmaceutical Development function, reporting to the functional area Head. 

The primary focus of the position will be executing unique methods required for protein formulation, characterization and stability testing. The position will characterize the biological activity and fate of AMT’s oral protein drug products in the developed formulation. The successful candidate can also work directly with vendors or contract laboratories (CROs), supporting drug development, methods and technology transfer.

Responsibilities:

  • Development and testing of protein formulations and characterization of degradation products.
  • Development and execution of assays for stability studies, regulatory filings and related activities for AMT drug products (including size exclusion chromatography, reduced capillary electrophoresis, and capillary isoelectric focusing).
  • Design and execute experiments to meet specific technical and regulatory objectives during research, development, optimization and validation of methods specific to AMT formulations.
  • Draft experimental plans and protocols and obtain approvals, as needed.
  • Prepare verbal presentations, technical memos and reports on the results of work performed.
  • Supervise Research Associates, Scientists or other lab staff.
  • Author controlled documents, as needed, created during release and stability testing of drug product.
  • Support qualification/trouble-shooting efforts, OOS/OOT and deviation investigations.
  • Support regulatory filings by contributing to the relevant drug product CMC sections.
  • Ensure to follow established priorities and demonstrate effective time management in planning and execution of work.


Requirements:

  • A PhD degree in chemistry/biochemistry/chemical engineering or related field with 7+ years industry experience (or MS with 12+ years industry experience) in biopharmaceutical formulation development.
  • Hands on experience and knowledge in current approaches for biologics formulation development, biophysical and biochemical characterization of proteins, protein stability, and analytical method development is required.
  • Experience working with proteins (non-Ig) as well as MAbs is preferred.
  • Experience with relevant methods, such as ELISA, cell-based binding assays, UV, SDS-PAGE, HPLC, UPLC, capillary electrophoresis systems, spectroscopy, and rheology.
  • Experience with high throughput assay implementation.
  • Expertise in developing phase-appropriate formulations for protein therapeutics, including experience with IND filings.
  • Understanding of protein lyophilization and spray drying process development.
  • Candidate should have working knowledge in Design of Experiments and statistical principles.
  • A good understanding and adherence to Good Laboratory Practices and/or Quality Control-related cGMPs as applicable.
  • Hands-on laboratory experience and skills working with proteins.
  • A good understanding of the current US/EU regulatory and quality requirements and standards relevant to biologics drugs development.
  • Excellent verbal and written communication skills.
  • Proven ability to present at National/International Scientific Meetings and produce high quality publications in peer-reviewed journals.
  • Team-oriented work style, with effective conflict-resolution and stake-holder management skills.
  • Adjustability to changing priorities and timelines with willingness and ability to multi-task.
  • Ability to work independently in a small group setting with limited operational support.
  • Small and large company experience is preferred.


 Notes:

This position requires candidates to present a scientific presentation in a seminar during the interview.
Applicants are expected to include a cover letter highlighting how their qualifications match our needs.

 
Location: South San Francisco