Senior Scientist II, Drug Product
Company: Revolution Medicines
Location: Redwood City
Posted on: June 2, 2025
Job Description:
Revolution Medicines is a clinical-stage precision oncology
company focused on developing novel targeted therapies to inhibit
frontier targets in RAS-addicted cancers. The company's R&D
pipeline comprises RAS(ON) Inhibitors designed to suppress diverse
oncogenic variants of RAS proteins, and RAS Companion Inhibitors
for use in combination treatment strategies. As a new member of the
Revolution Medicines team, you will join other outstanding
scientists in a tireless commitment to patients with cancers
harboring mutations in the RAS signaling pathway.The
Opportunity:Playing a critical role as the subject matter expert
(SME) and project lead of Drug Product team within the
Pharmaceutical Development and Manufacturing (PDM) function, the
position will be responsible for end-to-end drug product
development focused on late-stage development, formulation and
process optimization, scale-up and validation in support of RVMD
pipeline compound development and eventual commercialization.
Responsibilities will include:
- Lead or support drug product development activities to advance
new chemical entities (NCEs) from early development stage through
commercialization.
- Design and oversee formulation and process development,
clinical manufacturing, scale-up, technology transfer, process
optimization, and process validation activities related to solid
oral dosage drug products at CDMOs.
- Manage GMP manufacturing of drug products to support clinical
studies, primary stability, and process validation.
- Author and/or review technical reports and CMC-related
documents required for regulatory submissions.
- Design and manage process development studies using a
quality-by-design approach. Study and identify critical quality
attributes (CQAs) and critical process parameters (CPPs) for drug
products. Explore and establish proven acceptable ranges and
control strategies for drug product manufacturing.
- Collaborate with cross-functional teams, including but not
limited to Clinical Supply, Quality Assurance, Analytical
Development and QC, Drug Substance, Project Management, Regulatory
Affairs, and Research teams, to achieve project goals in a timely
manner and assist in driving decision-making.
- Travel to CRO/CDMO sites for the oversight of development and
manufacturing activities (up to 20%).Required Skills, Experience,
and Education:
- A graduate degree in Pharmaceutical Science, Chemistry,
Chemical Engineering, or closely related field is desirable.
- 10 + years of experience in the pharmaceutical/biotech industry
with end-to-end drug product development and manufacturing
experience of small molecules.
- Thorough understanding and hands-on experience with
pharmaceutical drug products including GMP, quality systems, ICH
guidelines, FDA, EMA, and associated regulatory requirements.
- Relevant experience in late-phase drug product development and
commercial development with CMC regulatory filings for US (NDA),
Europe (MAA), Japan, and China.
- Excellent communication (both verbal and technical) and
problem-solving skills.
- Working experience in managing and overseeing development and
manufacturing activities at CDMOs.
- Ability to multi-task and thrive in a fast-paced innovative
environment.Preferred Skills:
- PhD in degree in Pharmaceutical Science, Chemistry, Chemical
Engineering, or closely related field is desirable.The base salary
range for this full-time position is $164,000 to $205,000 for
candidates working onsite at our headquarters in Redwood City, CA.
The range displayed on each job posting is intended to be the
salary for an individual working onsite in Redwood City and will be
adjusted for the local market a candidate is based in. Our salary
ranges are determined by role, level, and location. Individual pay
is determined by multiple factors, including job-related skills,
experience, market dynamics, and relevant education or
training.Please note that base salary is one part of the overall
total rewards program at RevMed, which includes competitive cash
compensation, robust equity awards, strong benefits, and
significant learning and development opportunities.Revolution
Medicines is an equal opportunity employer and prohibits unlawful
discrimination based on race, color, religion, gender, sexual
orientation, gender identity/expression, national origin/ancestry,
age, disability, marital status, medical condition, and veteran
status.Revolution Medicines takes protection and security of
personal data very seriously and respects your right to privacy
while using our website and when contacting us by email or phone.
We will only collect, process and use any personal data that you
provide to us in accordance with our and . For additional
information, please contact .
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Keywords: Revolution Medicines, San Jose , Senior Scientist II, Drug Product, Other , Redwood City, California
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