Sr Scientist II (Process and Lab Manager)

Exelixis Inc.•Alameda, CA

61d

About The Position

The Senior Scientist II (Process and Lab Manager) focuses on research using equipment in process and high potency labs (including but not limited to, HPLC, Karl Fisher, Reactarry, LC/MS, GC/MS, NMR, flow reactor, RCI, DSC, TGA, XRPD, PLM, milling equipment) to define process reaction, safety parameter, solid characterization of intermediate and final API. The Senior Scientist II will work as a process chemist to evaluate and develop IPC methods for early-stage discovery projects to facilitate a smooth scale up for supply of compounds for pre-clinical and IND enabling studies. This person will also perform tech transfers of IPC and release methods, which are developed in the lab and transferred to the internal analytical group and CDMO for clinical manufacturing. This person will also work with project teams to identify process impurities and partner with chemists to develop safe, reproducible and scalable processes.

Requirements

Bachelor's degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 9 years of relevant experience in the biotech/pharmaceutical industry; or,
Master's degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 7 years of relevant experience in the biotech/pharmaceutical industry; or,
PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 2 years of relevant experience in the biotech/pharmaceutical industry; or,
Equivalent combination of education and experience.
A demonstrated track record of delivering results with high integrity, quality focus and collaboration.
Knowledge of characterization of the physical and chemical properties of compounds of interest.
Knowledge of process chemistry, synthetic organic chemistry, analytical methods (MS and HLPC, Karl Fisher, Reactarry, LC/MS, GC/MS, flow reactor, RCI, DSC, TGA, XRPD, PLM and milling) for physical-chemical characterization of compounds.
Excellent interpersonal skills, oral and written communication skills.
Excellent organizational skills, with ability to successfully manage multiple priorities.
Ability to work effectively with cross-functional teams.
Highly self-motivated and detail-oriented, with proven ability to work independently.

Responsibilities

Work with process teams to facilitate scale up of building blocks, intermediate and drug candidates.
Maintains equipment in good working condition and troubleshoots issues.
Manages inventory for internal intermediate and API and for CDMOs.
Partners with chemist to evaluate and develop IPC method for early-stage discovery products. Facilitates smooth scale up for supply of compounds.
Execute all required data using analytical and safety equipment to support in-house process development and optimization studies to facilitate scale up and transfer to CMOs.
Collaborate with project team to source appropriate quality of starting materials.
Prepare technical packages for transfer of processes parameter defined to internal analytical lab and CMO/CRO partner facilities.
Keeps abreast of relevant publications and guidance documents.

Benefits

comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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