Sr. Manager, Clincal Supply Chain

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/.

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