Scientist II, Analytical Development

Revolution Medicines • Redwood City, CA

1d • Hybrid

About The Position

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a critical role within CMC function, as a scientist, the analytical development position will support the manufacturing and control of drug substances and drug products during clinical development. The position will provide analytical support to formulation development and API process research and development and assist in regulatory filings supporting Revolution Medicines pipeline compound development and clinical programs.
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 achieve project goals timely.

Requirements

• 5+ 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.
• 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

• Preferably a graduate degree in analytical chemistry, organic chemistry or a related discipline.

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 achieve project goals timely.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level