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/.

This position is responsible for developing and managing CMC Supply Chain supplier relationships and for creating needed infrastructure for all regulatory permitting, material planning, inventory control, SOPs, CRO/CMO site receiving and depot activities. Under the general supervision of the Director, Technical Operations, this position will manage Supply Chain-related activities around Pre-Clinical and Clinical Trial Material (PC/CTM) and Investigational Medical Product (IMP). They will provide input and oversight to ensure all tactical operations meet or exceed cGMP regulations, ensuring high level of quality of our clinical and commercial supply chain processes. This position may also manage one or more Clinical Supply Chain Specialists.

What You’ll Do

Develop, build, and manage clinical study material forecasts, supply plans, and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company’s internal procedures and GxP requirements.
Responsible for managing compliance with customs and trade requirements for Pre-Clinical and Clinical Trial Material global shipments.
Coordinate CTM and ancillary supplies (if necessary) shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites
Actively manage and coordinate activities at Drug Product Filling, Labeling, Packaging, and Supply Depot sites in Europe, the Asia-Pacific Region, and US.
Able to coordinate courier shipments and deliveries. Manage the courier relationship. Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
Manage the label design and construction as well as the day-to-day labeling operations and packaging activities at the CMO site
Establish and coordinate the packaging design based on Clinical protocols and manage all packaging activities including contractor packaging records and monitoring work and timelines at contractors
Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives.
Lead or participate in necessary vendor selection processes, obtaining RFPs, establishing competitive bids and negotiation of agreements.
Onboard and manage relationships with contract organizations, including establishing agreements, quotes, purchase orders and invoicing. Assist Finance with inventory reconciliation and financial close.

What You’ll Bring

BS or Master's Degree in life sciences, Supply Chain Management, Operations Management or related field (or equivalent experience)
4-8 years' experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
Preferably Certificate in a Supply Chain Management Program or equivalent
Ability to work independently to make strategic decisions related to planning, and budgeting.
Understanding of cGMP's and pharmaceutical industry procedures and regulations
Strongly preferred to have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience
Must have strong, open and transparent communication skills (verbal and written)
Solid organizational and time management skills
Experience with: MS Office Suite and GSuite
Ability and willingness to travel 10% of the time (internationally and domestically) post-COVID restrictions

About Us

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 accomodations-ext@23andme.com. 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.

Pay Transparency
23andMe takes a market-based approach to pay, and amounts will vary depending on your geographic location. The salary range reflected here is for a candidate based in the San Francisco Bay Area. The successful candidate’s starting pay will be determined based on job-related skills, experience, qualifications, work location, and market conditions. These ranges may be modified in the future.

San Francisco Bay Area Base Pay Range

$145,000—$217,000 USD

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Sr. Manager, Clinical Supply Chain

Therapeutics - Therapeutics Development

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