Associate Director/Director, CMC Technical Operations (Biologics)

Associate Director/Director, CMC Technical Operations (Biologics)

SUMMARY:

Local Boston based biotech is looking to hire a dynamic and motivated Associate Director/Director to develop and execute on our technical operations for biologics development and manufacturing. The successful candidate will oversee CDMO diligence and selection, technology transfer, process optimization, characterization and validation, method validations, manufacturing, stability, and lot disposition. 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 GMP CDMO manufacturing partners in support of CMC technical operations
  • Manage necessary audits (remote and in-person) and serve as person in plant (PIP) for GMP manufacturing across sites in US and EU
  • Lead all forms of cell line development, upstream/downstream process optimization, characterization, validation, PPQs to facilitate late-stage manufacturing campaigns (Phase 1 to commercial)
  • Manage all forms of late-stage formulation and analytical development, CQA establishment, qualification, validation, stability protocols, reference standard characterization, and GMP Drug substance release
  • Oversee and adapt towards necessary processes technology transfers as technical operations evolve from clinical to commercial preparedness
  • Contribute to the development and approval of batch records, phase appropriate control strategies, out of specification and out of trend investigations and implementation of non-GMP/GMP technical improvements
  • Partner 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 manufacturing campaigns at the CDMOs  
  • 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 (preIND, IND, BLA)
  • Identify industry trends and propose innovative solutions that support compliance and operational excellence

REQUIREMENTS:

  • BS/MS/PhD in biochemistry, biochemical engineering, biotechnology, or equivalent.  Candidate must have 8 to 12 years of experience in cell line and process development, optimization and validation, manufacturing, lot release in support of both early and late-stage clinical development 
  • Significant experience in upstream/downstream process development, characterization and validation studies including large molecules
  • Proven experience with successful IND and BLA submissions including biologics
  • Demonstrated experience in transferring processes, purification technologies, methods and manufacturing technologies, budget planning, outsourcing, raw material qualifications, release of GMP drug substances  
  • Demonstrated understanding of the interdependencies between GMP drug substance and drug product manufacturing, quality, clinical, and regulatory affairs
  • In-depth understanding of process, analytical and formulation development with relevant exposure to statistical data analysis
  • Must be well versed with regulatory requirements and guidance documents (FDA/EMA/ICH)
  • Ability to assess gaps, timely execution of strategies to minimize risks, and propose solutions to complex technology challenges
  • Strong problem-solving, troubleshooting, collaborative and written/oral communication skills
  • Ability to travel domestic and international (15% of the time) to perform audits and manage GMP operations (PIP)