Technical Development Scientist 2, Extractables/Leachables GC-MS/LC-MS

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The Opportunity

The Analytical Development organization prides itself on expertise and leadership in the area of process related impurities. We have an exciting opportunity for a talented scientist to join our team.

The position is focused on evaluating protein-based drug products for leachables, and characterizing extractables from a range of container systems and process equipment. The work will involve designing methods to characterize and quantitate extractables and leachables, collecting and interpreting data for a wide variety of protein-based therapeutics, and thoroughly documenting results.

A successful candidate will be capable of applying advanced GC-MS and LC-MS methods to evaluate small molecules and impurities in complex solutions. Direct experience applying these analytical methods to impurities or leachables analyses is required. The ability to become proficient in other methods, such as ICP-MS, is important.

This job requires strong organizational skills and the capacity to manage multiple simultaneous projects. The ability to plan, schedule, and track work for internal and external teams is essential. Documentation of results and authoring of protocols and summary reports are part of the position, so excellent written communication abilities are needed.

What You'll Do

• Plan and execute testing of protein-based drug products for small molecule leachable content.

• Evaluate in-house extractables data from container systems and process equipment.

• Review leachables data from contract research organizations (CROs).

• Review extractables data from vendors and other external sources.

• Apply knowledge in the areas of GC-MS and LC-MS for leachables testing and investigational purposes.

• Help support other analytical methods, such as ICP-MS.

• Troubleshoot instruments and methods.

• Communicate results to project teams and advise on the proper experimental design for E&L testing.

• Author protocols, summary reports, and regulatory submissions.

Who You Are

• Ph.D in Chemistry, Biochemistry, or related scientific field, or equivalent combination of Bachelor's/Master's and experience.

• 5+ years of experience and an advanced knowledge of small molecule LC-MS and GC-MS.

• Experience with extractables and leachables as related to primary container closure and process equipment.

• Strong organizational skills

• The ability to work well with a variety of project teams.

• A successful track record of written communication

The expected salary range for this position based on the primary location of South San Francisco, CA is $84,600 - $157,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.