Sr. Manager
Clinical Supply Chain
Confirmed live in the last 24 hours
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Communications
Requirements
- 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
Responsibilities
- 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
Personal genomics & biotechnology company
Company Overview
23andMe’s mission is to help people access, understand, and benefit from the human genome. The company has created the world’s largest crowdsourced platform for genetic research and is the only company with multiple FDA authorizations for genetic health risk reports. The company is also in development of discovery programs rooted in a diverse spectrum of human genetics to ultimately deliver reports and results from all spectrums of your DNA.
Benefits
- Comprehensive health, vision, & dental plans
- Family planning, support, & leave for parents
- Mental healthcare
- Student loan assistance
- Volunteer time off
- Dog friendly office
Company Core Values
- Think big
- We heart DNA
- Lead with science
- Get to yes or no, quickly.
- Behind every data point is a human being
- We're in this together