Applied Molecular Transport (AMT) is growing its R&D organization to enable various aspects of its CMC and product development activities required to bring its biopharmaceuticals to clinical testing. AMT’s novel, proprietary technology platform allows for the efficient delivery of biopharmaceuticals across the intestinal epithelium. 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 unattainable or unappreciated biological outcomes for agents delivered by the oral-GI route.

Position Description


An immediate opening exists for a Principal Scientist, Protein Analytical Development to join the newly formed Analytical Sciences group, reporting to the group Head. 

The primary focus of the position will be executing unique methods required to characterize the chemical and physical properties of AMT’s biological therapeutics, as well as to develop relevant assays to guide downstream protein production method development. This position will be expected to support in vivo PK/PD assessments in a fast-paced environment. The successful candidate can also work directly with vendors or contract laboratories (CROs), supporting drug development, methods and technology transfer.

Responsibilities:

  • Development and execution of routine and innovative chromatographic and spectrometric methodologies for the identification, in-depth characterization and quantification of proteins from simple and complex matrices, to include structural and functional characterization, release testing, comparability, stability studies, regulatory filings and related activities for AMT drug substances and drug products.
  • Method development and method qualification; method validation experience is a strong plus.
  • Design and execute experiments to meet specific technical and regulatory objectives during development, optimization, and validation of methods specific to AMT Drug Substance and formulations (Drug Product).
  • Draft experimental plans and protocols, and obtain agreement/approval, as needed.
  • Lead the development and drafting of analytical Quality documents (Certificates of Analysis or Certificates of Testing) for protein therapeutics.
  • Prepare verbal presentations, technical memos and reports on the results of work performed.
  • Author controlled documents, as needed, created during release and stability testing of drug substance and drug product.
  • Support regulatory filings by contributing to the relevant 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 or related field with 10+ years industry experience in a protein analytical sciences role.
  • Deep experience in sample preparation and analytical techniques for biological products and impurity characterization, to include spectroscopic and photometric methods, chromatographic methods (e.g., GC, Partition, Ion exchange, SEC, HPLC, MS/LC-MS), electrophoretic methods and bioassays.
  • A good understanding and adherence to Good Laboratory Practices and/or Quality Control related cGMPs, as applicable.
  • Hands on and leadership experience to advance biological therapeutics from preclinical to clinical development.
  • Hands-on laboratory experience and skills working with proteins.
  • Solid understanding of the current US/EU regulatory and quality requirements and standards relevant to biologics drugs; experienced in contributing to IND filings.
  • Excellent verbal and written communication skills.
  • Proven ability to present at National/International Scientific Meetings and produce publications in high quality peer-reviewed journals.
  • Team-oriented work style, with effective conflict-resolution and stake-holder management skills.
  • Experience in a successful biopharmaceutical organization, preferably including small companies.
  • 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.


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, CAType your paragraph here.