Technical Development Principle Scientist

Roche • South San Francisco, CA

1d

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech! In Pharma Technical Development (PTD), we actively collaborate and develop creative technical solutions to efficiently transform scientific ideas into products. Our mission is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication and mutual respect, and contributes every single day, continuously improving what it does. Our global Analytical Development and Quality Control (ADQC) organization is a leader in developing, validating and executing physicochemical, immunochemical, and biological methods for our biologics pipeline. This function provides integrated analytical control strategies and systems that enable CMC development of biologic therapeutics, process development, product characterization, and drug delivery for biologic products from research (molecular assessment) through post product launch. The Opportunity A Technical Development Principle Scientist position is available in the Analytical Development Department (within Pharma Technical Development organization). The selected candidate will participate as the analytical expert in a multi-disciplinary CMC (chemistry, manufacturing, and controls) team and will contribute to the development of several active clinical (phase 1-3) therapeutics simultaneously. The candidate will be responsible for designing and executing analytical studies that support process development and enable successful regulatory filings (IND, BLA). The successful candidate will have sound analytical chemistry fundamentals and an eagerness to flex between diverse analytical techniques including but not limited to high performance liquid chromatography, mass spectrometry, capillary electrophoresis, advanced spectroscopy. Who you are

Requirements

• Ph.D. (4-6 additional years experience), M.S./B.S. (6-10 additional years experience) in Analytical Chemistry, Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline
• Sound fundamental knowledge in the analytical characterization of proteins or related therapeutic modalities
• Well-rounded practical experience in the application of high performance liquid chromatography, liquid chromatography-mass spectrometry, capillary electrophoresis, and advanced spectroscopy with at least one area of deep analytical expertise
• Knowledgeable about CMC (chemistry, manufacturing, control) development from Phase I to commercial
• Self-motivated, have excellent organization, oral and written communication skills, and be willing to work both independently and as a team member.
• The candidate is expected to present data at internal and external meetings when appropriate.
• Willing to work in a dynamic, fast-paced environment, and be capable of driving tasks to completion in a timely fashion.

Nice To Haves

• Prior experience with small molecule linker drugs and antibody-drug conjugates (ADCs)
• Prior experience supporting IND-enabling and BLA-enabling activities

Responsibilities

• designing and executing analytical studies that support process development
• enabling successful regulatory filings (IND, BLA)

Benefits

• Relocation benefits are available for this job posting.
• The expected salary range for this position based on the primary location of South San Francisco, CA is $120,800 - $224,300.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree