Clinical Supply Chain Manager
The Clinical Supply Chain Manager is responsible for leading the distribution of investigational drug, comparators and ancillary supplies for Selecta’s lead clinical product, SEL-212. Position will oversee and work closely with the CRO, CMO and IXRS vendors in an unblinded role in drug management and clinical supply for phase 2 and 3 clinical studies on a global scale.
- Oversee and partner with CRO, external vendors and unblinded team members to maximize drug supply efficiency.
- Oversee vendor activities including procurement, IWRS development, on-time delivery, quality, improvement initiatives, and issue resolution
- Responsible for the logistical support for packaging, labeling and shipment of clinical drug supplies to depot/clinical trial sites as well as other clinical supplies
- Manage and monitor inventory levels at CMO, depots and clinical sites for supported studies through the life of the trial; take preventive actions to avoid potential supply issues
- Along with clinical operations, develop IRT supply specifications. Act as primary contact for developing and maintaining IWRS system, participating in and overseeing effective UAT as applicable
- Manage direct outsourcing of labeling, packaging and distribution of manufactured drug supply and co-administered and/or comparator supplies, as required, to global sites
- Review and evaluate inventory reports to insure demand requirements are met and prepare supply plans
- Monitor and track shipments to ensure smooth transit through the logistical path –including international shipping at appropriate stability temperatures. Support evaluation of OOT an OOS temperature excursions for clinical supplies.
- Identify, document and escalate major/critical issues to the clinical trial team while maintaining the blind when applicable
- Manage vendors and their respective contracts, invoice review, and budget planning
- Work collaboratively and transparently while maintaining the blind when applicable with Clinical Operations, CMC, Quality Assurance and Regulatory Affairs
Education and Experience Requirements
- Bachelor’s degree in a science-based subject
- Minimum 7 years’ experience within pharmaceutical/biotech/life sciences industry
- At least 5 years direct experience in clinical supplies environment, including global studies
- Must be knowledgeable in clinical supply cGCPs, GDPs and relevant US, EU and global regulations governing supply chain activities
- Clinical trial supply experience with biologics and intravenous products desired
- Prior Cold Chain distribution experience required
- Extensive prior experience in clinical supply management, including forecasting, logistics (labeling, packaging, distribution, expiries), inventory tracking and managing IRT
- Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
- Experience in establishing and maintaining relationships with vendors
- Working knowledge of current GMP/GCP regulations required
- May require business travel, domestic and international, to various suppliers and partners as needed
Special Skills / Knowledge
- Provide a hands-on approach to problem solving and troubleshooting
- Very good communication, negotiation and interpersonal skills
- Excellent planning and project management skills
- Demonstrate a high degree of ethics, trustworthy, and confidentiality
- Exhibit accuracy and attention to detail
- Ability to work with tight deadlines, budgets, and changing environment
- APICS certification (CPIM, CRIM, CSCP) preferred
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP) to a range of biologics for rare and serious diseases that require new treatment options. The company's current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company's lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts.
For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.
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Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).