Associate Director, Analytical Development – CMC

REVOLUTION Medicines, a clinical stage biotech company, dedicated to discovering and developing new drugs that translate frontier cancer targets through exceptional drug discovery delivering revolutionary medicines on behalf of cancer patients.  Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.  As a new member of the RevMed team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

Opportunity

Playing a critical role within CMC as the technical / project / functional lead of Analytical Development, the ideal candidate will be responsible for analytical activities including development, qualification, validation and transfer of analytical methods, specification development, support of lot release, stability studies, and special studies for API and drug product development and manufacturing. Other responsibilities for the role include:

  • Apply technical proficiency to the planning, execution and management of analytical activities at Contract Development and Manufacturing Organizations (CDMOs) and/or Contract Testing Laboratories (CTLs).

  • Review of raw data packages associated with method development, qualification, validation or transfer, release testing, stability testing, and other characterization testing of API and drug products.  

  • Ensure the timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory drug submissions, etc.

  • Maintain an organized system for tracking and archiving of GMP and non-GMP analytical and research data and documentation for successful regulatory filings.

  • Work closely with Quality and other CMC functional leads to assure high quality is maintained for work performed at CDMOs and/or CTLs.

  • Participate in the vendor (CDMO and/or CTL) selection and qualification process as needed.

Required Skills
  • Preferably a Ph.D. (minimum a MSc.) in analytical chemistry, organic chemistry, pharmaceutical science or related discipline with ideally 10+ years of analytical science and development experience in the biotech/pharma industry with a track record of scientific and project leadership.  

  • Knowledgeable in analytical techniques such as HPLC/UPLC, GC, FTIR, UV-Vis, KF, NMR, ICP-MS and other USP methods with hands on experience and expertise analytical techniques and troubleshooting instrumentation.

  • Sound understanding of the principles and practices of analytical science and development applicable to NME / API and pharmaceutical product development.

  • Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines, and related industry practices.

  • Sound understanding of CMC regulatory requirements and direct experience with compiling CMC sections (IND, IMPD and NDA) is preferred.

  • Proven ability to multi-task and handle multiple projects simultaneously with strong problem skills and decision-making ability.

  • Excellent organizational skills, detail oriented and thrives in a collaborative team setting.

  • Effective communication skills (verbal, written and technical) and interpersonal skills.

  • Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.


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