Technical Development Senior Principal Scientist
4 weeks ago
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, a member of the Roche Group.
The Opportunity
A Senior Principal Scientist position is available in Genentech's Technical R&D, Analytical Development and Quality Control team.
The individual will lead a multidisciplinary team of analytical, biological, and quality control scientists in support of the CMC deliverables for protein-based clinical development candidates. Additionally, they will represent Analytical Development and Quality Control on cross-functional project teams, where they will collaborate with leads from other functions on all aspects of CMC project deliverables. The scope of supported projects includes those in both early- and late-stage clinical development, with accountability for key deliverables such as developing suitable analytical/biological methods and establishing patient-centric specifications, physicochemical and biological characterization strategies, critical quality attribute identification, devising comparability strategies, and implementing reference standards. As the accountable lead for these activities, the candidate will also collaborate often with representatives from non-clinical, clinical, and regulatory functions. Additionally, the individual will be responsible for authoring sections in regulatory filings, as well as responses during Health Authority Q&A. As a key member in developing product control strategies, the individual will also have opportunities and responsibility to contribute to broader, company-wide and external strategic initiatives that may result in innovations that improve our efficiency and further optimize the patient-centric approaches that enable success on CMC deliverables.
Who You Are
Requirements:
PhD in Chemistry or Biology with a minimum of 8 years of industry experience is strongly preferred
Hands-on technical and leadership experience supporting analytical and control strategy elements on CMC project teams
Extensive practical and theoretical expertise in process and analytical development and manufacturing, with deep understanding of the drug development process
Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams
Strong written and verbal communication skills are required
The expected salary range for this position based on the primary location of South San Francisco, CA is $140,500 to $260,900. Annual 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.
Relocation benefits are available for this job posting.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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