Job Title: Director/Associate Director, Supply Chain Management
Job Number: 25296
Location: Lexington, MA
The Director / Associate Director of Supply Chain Management will be responsible for planning and overseeing our external development, manufacturing, and procurement of all reagents, starting materials, and consumables for our internal and external drug substance and drug product manufacturing. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role is part of a team focused on development and manufacturing of a novel mRNA technology. This role requires management skills and technical knowledge, preferably with biologics, lipid-based, and/or particle-based drug delivery systems, and knowledge of analytical characterization of complex formulations. Also general operations knowledge for chemical synthesis, product packaging, vial filling, lyophilization, distribution, facilities, and other business operations. Finally, the candidate will liaison with Program Management and Clinical to build and maintain product inventory and build demand forecast models.
The successful candidate is expected to have a background in formulation development, process engineering, or chemistry with 5+ industry experience in supply chain management, pharmaceutical development, process development, manufacturing, or technology operational management.
- Act as primary liaison with CMOs and suppliers to ensure raw material supplies meet demand needs for drug substance, bulk drug product, and fill/finish manufacturing operations. This will include production demand planning, Person-in-Plant (where applicable and possible), Executed Batch Record review and issue resolution, deviation / investigation support and closure, and support of raw material release by QA.
- Oversee the technology transfer and outsourcing of reagent synthesis and characterization assays to third party contract organizations, including cGMP starting materials and other critical raw materials.
- Manage vendors for reagent supply, characterization, and packaging.
- Negotiate favorable pricing for Translate’s supply needs. Create supply agreements or in-licensing opportunities with vendors as appropriate.
- Work with clinical group to provide suitable kits for product distribution of our internal products.
- Work with our corporate partners on the hand-off of the supply chain and distribution for our partnered products.
- Oversee and ensure success of Tech Transfer (TT) activities from Translate to CMO partners. This will include drafting Requests for Proposal, vendor identification, evaluation, and selection, development of a comprehensive tech transfer plan and schedule, ensuring alignment with the drug substance and drug product needs, review and approval of raw material / consumables procurement plans, and coordination with Analytical Development on analytical method transfer / qualification / validation.
- Ultimately managing a staff capable of complete inventory management and procurement of all materials required by Translate Bio Technical Operations, and playing an integral role in establishing an enterprise resource planning system and/or material requirement planning system for our operations.
- Review and audit of CMO invoicing prior to approval for payment. Prepare campaign summary reports as required.
- Manage Vendor Change Notifications (VCN), generation and closeout of Change Controls for VCNs, and inventory management with respect to VCNs.
- Organize, evaluate, and communicate data in an effective and scientific manner
- Assume additional responsibilities as assigned.
- 10-15+ years of relevant experience in the biopharmaceutical industry.
- College or advanced degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences, coupled with an understanding of analytical chemistry. Advanced degree in business or management is not required but preferred.
- Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices. Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.
- Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication. Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Translate Bio’s scientific and business goals.
- Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
- Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
- Experience in CMO search, evaluation, selection, and management and familiarity with request for information and request for proposal processes.
- Results oriented and demonstrates a focus on achieving (business) results.
- Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
- Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production.
- Ability to travel (U.S./ Int’l) 25-50% of time, particularly when production campaigns are being done.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.