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CMC Process Development Lead
South San Francisco, California, United States
Who We Are
23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.
This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
The CMC Process Development Lead will oversee the upstream and downstream development and early manufacture of therapeutic biologics. The individual will join a highly collaborative cross-functional team to advance therapeutic candidates from early development to commercialization.
The ideal candidate for the position is expected to provide both technical and strategic leadership for process development, optimization, scale-up, process characterization, process validation and IND/BLA-enabling activities. S/he will work closely with the CDMOs to build and maintain strong working relationships with internal and external partners. S/he may be responsible for designing and building in-house CMC process development in a fit-for-purpose timescale. S/he will also be responsible for the preparation of CMC contents for regulatory submissions and correspondences, in collaboration with other CMC functional leads. S/he will be responsible for recruiting and hiring additional personnel as needed for organizational growth, and will be an experienced manager with a demonstrated track record for motivating and mentoring reports.
What you'll do:
- Provide technical leadership to guide external CMC process development through process and method development, optimization, qualification and validation at selected CDMOs.
- Provide strategic input to develop and establish CMC strategy, direction and decision-making process for development programs of biologics.
- Serve as the CMC lead to actively manage CMC progress, to drive effective decision-making and execution and to communicate with the cross-functional teams regarding progress against program milestones.
- Identify and implement novel technologies and/or strategies to address any technical challenges during the manufacturing process in support of immediate manufacturing needs and to enable innovation of future process development.
- Work with Regulatory, QA and Senior Management to ensure that all SOPs, company and external manufacturing activities are in full compliance with relevant regulations.
- Author, review and approve study reports, batch records and CMC sections for regulatory submissions and responses.
- Work closely with the IT department to implement data management systems and to ensure well-organized, clear and complete records of all internal and external CMC activities.
- Motivate, inspire, and when needed, recruit and manage employees in the CMC function.
- Approximately 5-10% of domestic and/or international travel.
What you’ll bring
- Ph.D. or Master’s degree with significant Biotechnology or Manufacturing work experience
- Extensive knowledge and hands-on downstream experience with previous track record of process development experience in upstream and downstream such as cell culture, feeding strategy, filtration, chromatography, viral clearance, etc. Experience with statistical design of experiments and/or high-throughput automation technologies is a plus.
- Experience in managing internal team and external CDMOs
- Demonstrated ability to work efficiently in a fast-paced, team-oriented environment
- Excellent oral and written communication
- Self-motivated with a passion to develop and implement novel technologies and strategies to improve CMC process development.
- Excellent record keeping abilities to adequately record, analyze and document data generated in support of SOPs and regulatory requirements.
- Experience with gaining FDA and/or other regulatory authority approval for biologics is highly preferred
Note: Job title will be commensurate with experience and academic credentials.
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at firstname.lastname@example.org. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.Back