Sr Scientist I (Process Chemistry)

Exelixis • Alameda, CA

11d • $116,000 - $165,500

About The Position

The Senior Scientist I, Process Chemistry, will focus mainly on executing in-house process chemistry efforts at Exelixis process research and development lab. This individual will work with medicinal discovery chemist to evaluate synthetic routes for early-stage discovery projects to facilitate smooth scale up for supply of compounds for pre-clinical studies, understand the physical and chemical properties of compounds of interest and perform solid state polymorph screening to define the stable polymorph for DS manufacturing, tech transfer the processes developed in lab to CMO for clinical manufacturing and work with project teams for troubleshooting and problem solving for ongoing manufacturing projects.

Requirements

• Bachelor’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,
• Master’s in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 5 years of relevant experience in the biotech/pharmaceutical industry; or,
• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field with 0 or more years of relevant experience in the biotech/pharmaceutical industry; or,
• Equivalent combination of education and experience.
• Demonstrated track record of delivering results with high integrity, quality focus and collaboration.
• Knowledge of process chemistry, synthetic organic chemistry, analytical methods (especially NMR, MS and HPLC) and 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

Nice To Haves

• Experience of solid state characterization and polymorph screening is a plus.
• Proven ability to develop, optimize and scale up drug substance manufacturing processes and demonstrated skills to manage GMP contract manufacturing organizations will be a plus.

Responsibilities

• Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of both target compounds and building blocks while providing insights for selection of development candidates.
• Execute in-house process development and optimization studies to facilitate scale up and transfer to CMOs.
• Collaborate with project team to source appropriate starting materials.
• Prepare technical packages for transfer of processes to CMO/CRO partner facilities.
• Knowledge of characterization of the physical and chemical properties of compounds of interest and perform solid state characterization and polymorph screening.
• Partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to ensure drug substances are delivered on time and within specification.
• Write and review CMC sections of regulatory filings when needed.
• Keep abreast of all 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees