Senior Scientist I, Analytical Development
About The Position
Playing a critical role within CMC function, as Senior Scientist I, Analytical Development the position will support the manufacturing and control of drug substances and drug products during clinical development. The position will provide analytical support to API process research and development, formulation development, and assist in regulatory filings in support of Revolution Medicines pipeline compound development and clinical programs. Specifically, you will be responsible for: Provide support and oversight to analytical development activities, such as method development, method validation and testing, at contract partner sites to ensure outsourced activities are executed successfully and meet the objectives. Provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings. Critically review data packages associated with method validations, release testing, and other characterization testing for drug substances and drug products. Collaborate with cross functional teams in the establishment of control strategy and setting specifications for drug substances and drug products. Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document. Communicate technical findings to colleagues and collaborators within formal and informal settings, including cross-functional project team meetings. Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals. Present work and results in team and group meetings.
Requirements
- Ph.D. with a min of 5 years industry experience or MS degree with a min of 8 years of relevant industrial experience in analytical development.
- Technical knowledge of analytical technologies including HPLC/UPLC, XRPD, LCMS, DSC, DVS and Dissolution.
- Experience managing projects at CROs/CDMOs.
- Experience with analytical method development, validation and method transfer.
- Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
- Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
- Strong problem-solving skills with sound technically driven decision-making ability.
- Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
- Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
- Ability to multi-task and thrive in a fast-paced innovative environment.
Nice To Haves
- PhD or MS in analytical chemistry, organic chemistry, or related discipline.
- CMC experience with small Molecules is strongly desired, and experience in solid oral dosage is a plus.
- Familiarity with document management systems (such as Veeva or similar).
Responsibilities
- Provide support and oversight to analytical development activities, such as method development, method validation and testing, at contract partner sites to ensure outsourced activities are executed successfully and meet the objectives.
- Provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.
- Critically review data packages associated with method validations, release testing, and other characterization testing for drug substances and drug products.
- Collaborate with cross functional teams in the establishment of control strategy and setting specifications for drug substances and drug products.
- Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.
- Communicate technical findings to colleagues and collaborators within formal and informal settings, including cross-functional project team meetings.
- Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.
- Present work and results in team and group meetings.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
