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CMC Clinical Supply Chain Manager
South San Francisco, California, United States
Who we are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
Our Therapeutics team, which was established more than five years ago, has been actively identifying novel drug targets using 23andMe’s unparalleled database and developing a portfolio across several therapeutic areas, including oncology, cardiovascular and metabolic disease.
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, and CRO/CMO site receiving and depot activities. Under the general supervision of the Sr. Manager, CMC 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.
What you’ll do:
- Develop and build 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 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 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 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)
- 3-6 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
- 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
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 email@example.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.Back