Senior Manager/Associate Director, CMC supply chain

Senior Manager/Associate Director, CMC supply chain

SUMMARY:

Boston based biotech looking to hire a dynamic and motivated Senior Manager/Associate Director to develop and execute on our supply chain operations towards small and large molecule pipeline programs. The successful candidate will oversee vendor diligence and selection, audits, storage, packaging, labeling, and shipment of GMP supplies to clinical trial sites and other supply chain activities. Reporting to the Senior Director and Head of CMC, this position will collaborate with a highly diverse team of experienced professionals with an excellent opportunity for career growth.

RESPONSIBILITIES:

  • Lead diligence and collaborate with internal stakeholders to select reliable and experienced vendors and GMP partners in support of supply chain operations
  • Perform necessary audits (remote and in-person) for packaging, labeling, storage, and other relevant logistics operations across sites in US, EU and other markets
  • Serve as person in plant (PIP) for necessary GMP operations across sites in US, EU, and other markets
  • Review and approve label text, specifications, proofs, batch records, packaging, and distribution instructions for clinical products
  • Manage clinical supplies, leverage, and improve existing distribution (both control room and cold chain) network, coordinate shipment of GMP supplies to clinical sites in US, EU, and other markets
  • Oversee and adapt towards necessary processes technology transfers as supply chain evolves from clinical to commercial partners
  • Contribute to the development of phase appropriate control strategies, out of specification and out of trend investigations and implementation of relevant supply chain improvements
  • Collaborate with QA to establish quality agreements, audit reports, develop specifications, investigate deviations, and implementation of CAPAs
  • Ensure internal and external compliance with quality and regulatory in support of robust supply chain operations at the vendors
  • Collaborate with quality, regulatory, non-clinical, clinical, business development and project management to ensure alignment of program goals
  • Author sections of the CMC modules in support of regulatory submissions
  • Identify industry trends and propose innovative solutions that support compliance and operational excellence

REQUIREMENTS:

  • BS/MS/PhD in biochemistry, biochemical engineering, pharmaceutical sciences or equivalent.  Candidate must have 5 to 8 years of experience in developing supply chain operations towards labeling, packaging, kitting, and distribution of GMP supplies to clinical sites.
  • Relevant experience with supply chain operations supporting both small and large molecules
  • Proven experience in developing supply chain strategies, management and forecasting of clinical supplies, budget planning, outsourcing, raw material qualifications, release of packaged GMP drug products and successful delivery to clinical sites
  • Must be well versed with global import/export requirements and guidance documents (FDA/EMA/ICH)
  • Exposure to GMPs and GDPs of clinical and commercial products
  • Ability to assess gaps, timely execution of strategies to minimize risks, and propose solutions to complex supply chain challenges
  • Demonstrated understanding of the interdependencies between supply chain, logistics, GMP manufacturing, quality, clinical, and regulatory affairs
  • Strong problem-solving, troubleshooting, collaborative and written/oral communication skills
  • Ability to travel domestic and international (25% of the time) to perform audits and manage GMP operations (PIP)