Scientist II
Formulations Drug Product
Posted on 3/22/2024
Revolution Medicines

201-500 employees

Develops targeted therapies for RAS-addicted cancers.
Company Overview
REVOLUTION Medicines stands out in the oncology field for its unique approach to drug discovery, leveraging insights from nature and evolution to develop targeted therapies for RAS-addicted cancers. The company's robust drug discovery and medicinal chemistry capabilities have resulted in a deep pipeline of RAS inhibitors, with their most advanced product, RMC-4630, currently in a multi-cohort Phase 1/2 clinical program. This focus on genetic drivers and adaptive resistance mechanisms in cancer, coupled with their commitment to exploring mechanism-based dosing paradigms and in-pathway combinations, positions REVOLUTION Medicines as a leader in precision oncology.
Biotechnology

Company Stage

N/A

Total Funding

$1.3B

Founded

2014

Headquarters

Redwood City, California

Growth & Insights
Headcount

6 month growth

19%

1 year growth

53%

2 year growth

92%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Computational Biology
Biology Lab & Research
Biology & Biotech
Requirements
  • Preferably a graduate degree in pharmaceutical sciences, chemical engineering, physical organic chemistry or related discipline.
  • Ph.D. with 5 years of relevant experience or Master with 15+ years of experience in pharmaceutical development.
  • Experience in formulation and process development, DOE study, technology transfer, process scale-up, GMP manufacturing, packaging, and process validation of oral and /or parenteral drug products.
  • Hands-on experience in poorly water drug delivery technologies and enabling formulation development.
  • Knowledge of basic analytical skills required: HPLC, UV, solid state characterization, etc.
  • Knowledge and understanding of current ICH guidelines, GMP regulations, and related industry practices.
  • Working experience and knowledge of regulatory submission (IND, IMPD and / or NDA).
  • Excellent communication (both verbal and technical) and problem-solving skills.
  • Ability to multi-task and thrive in a fast-paced innovative environment.
Responsibilities
  • Lead or support drug product development activities to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization.
  • Responsible for form selection, formulation, and process development, scale-up, process optimization, clinical manufacturing and technology transfer of drug product from preclinical lead optimization stage through product launch.
  • Perform formulation of compounds for discovery and lead optimization, including intravenous, oral, subcutaneous, and intraperitoneal delivery to support pharmacokinetic, efficacy, and toxicity studies.
  • Plan and manage GMP manufacturing of drug products to support clinical studies, primary stability and process validation.
  • Execute preformulation related activities to define the physico-chemical properties of the active ingredient to define solubility, pKa, physical form screening, chemical stability, physical stability, solid state characterization (including SSNMR, DSC, TGA, PXRD, Raman, DVS, PLM).
  • Oversee the formulation and process development, technology transfer, process scale up and manufacturing activities at CMO.
  • Prepare, review, and/or approve manufacturing batch records, development and campaign reports, CMC regulatory submission document, study protocols and reports.
  • Design and manage process development studies using quality by design approach. Study and identify critical quality attributes and critical process parameters for drug product. Explore and establish the proven acceptable range and control strategy for drug product manufacturing.
  • Collaborate with cross functional teams including but not limited to Clinical Supply, Quality Assurance, Analytical Development, Process R&D, Project Management, Regulatory and Research teams to timely achieve project goals.
  • Design and execute studies in-house and/or through CROs/CDMOs to effectively screen candidates, to better understand delivery barriers of potential leads pertaining to the intended dosing route, and to enable candidate progression.
  • Participate in pre-clinical team and CMC team to provide pharmaceutical development / developability input to influence lead identification and optimization.
  • Travel to CRO/CDMO for the oversight of development and manufacturing activities (up to 20%).