Director of Chemistry, Manufacturing, and Controls

Arsenal Medical, Inc. is a Boston metro based, privately held, clinical stage, medical device start-up company committed to transforming medicine through the novel application of in situ forming materials to meet today's challenging unmet clinical needs. Our in situ forming biomaterials platform creates customized mechanical implants in the body to control the flow of bodily fluids, fill complex anatomical spaces, and/or apply physical pressure, as needed. These implants are formed by delivering liquids with tunable chemistries to specific locations in the body using minimally invasive delivery systems. Once at the target anatomy, the liquids react to form solid implants that take the shape of complex cavities in the body.

Arsenal Medical is seeking a Director of Chemistry, Manufacturing, and Controls (CMC), reporting to the President, who will be accountable for phase-appropriate CMC strategy. Responsibilities include oversight of the chemistry and formulation development efforts, the manufacture and distribution of clinical and commercial product, management of contract manufacturing organizations (CMO’s), and the assurance of product service levels and quality. We are looking for a consummate, hands-on team player who is willing to roll up their sleeves and also to lead in a small, collaborative environment.

Essential Functions

  • Collaborate with project leaders to provide leadership and technical oversight on all CMC-related development efforts
  • Establish and oversee process optimization, formulation development, analytical testing, aseptic fill and finished product manufacturing at external facilities
  • Oversee all aspects of CMC outsourcing including raw material and vendor selection, planning and reviewing technical content, leading technical and data driven decision making, negotiating plans, contracts, and supply agreements, holding CMOs accountable for performance, and internal and external auditing
  • Proactively manage risk mitigation strategies for critical path issues and program risks to ensure on-budget, timely delivery of program milestones and compliance with regulatory requirements
  • Author and review CMC sections of regulatory documents, study reports and other development related documents
  • Support Quality infrastructure in support of external CMC operations
  • Attract, retain, and develop a small team of scientific professionals

QUALIFICATIONS

  • Ph.D. in Chemical Engineering or related discipline preferred, with 7+ years of CMC experience in the medical device or life sciences industries working on polymer-based products
  • Must have technical depth and a broad understanding of chemical processes, analytical methods and formulation development
  • Expertise overseeing the validation / transfer of cGMP processes
  • Proficient in the management of Contract Manufacturing Organizations, leading GMP manufacturing activities, and managing product
  • Operational experience and familiarity with external regulatory requirements and cGMP. CMC project leadership experience is a plus
  • Well versed in authoring and reviewing CMC sections of regulatory submissions, and interactions with global regulatory agencies
  • Excellent communication and organizational skills; comfortable navigating complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors, and internal personnel
  • A track record of achieving results in a virtual/outsourced model is key
  • Demonstrated ability to develop and grow internal talent
  • Able to travel 20%

Please apply here

Arsenal Medical, Inc. is an Equal Opportunity Employer.