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Senior Manager - External Manufacturing Operations (Biotech)

  • Location: Boston
  • $ Salary: US$75.00 - US$85.00 per hour per hour
  • Job Type:Contract

Posted about 2 months ago

  • Sector: Life Sciences
  • Contact: Calum Nelson
  • Duration: 6 months
  • Start Date: 02/10/2023
  • Expiry Date: 22 November 2023
  • Job Ref: JN -092023-481562

*** This role requires API/Drug Substance experience ***

  • Location: Boston, Massachusetts (Hybrid)
  • Contract: 6 months, chance to extend/convert
  • 30-40% international travel
  • Full time (40hs p/w)
  • Pay Rate: $75-85/ph (depending on experience)

Job Description:

The Senior Manager in External Manufacturing is accountable for the successful execution of small molecule Drug Substance commercial manufacturing operation activities at our client's global external commercial partners.

Key Responsibilities:

  • Responsible for driving execution of Drug Substance production plans at CDMOs:
    • Act as main point of contact for CDMO(s)
    • Provide operational oversight and escalation support, to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management).
    • Identify and escalate business critical risks impacting supply and program timelines.
  • Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
  • Accountable for Supplier Relationship Management (SRM) for given CDMOs.
    • Responsibilities include strategic business review chairperson.
    • Identification and resolution of business/contract issues (collaboration across legal, CMSC LT, Strategy & Bus Ops, Finance and Strategic Sourcing teams).
    • Monitor CMO performance using a set of standard KPIs and report progress to management.
  • Partners with Global Supply Chain to develop long term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.

Education and Experience:

  • BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry, or related discipline
  • 8+ years of related experience of the equivalent combination of education and experience with 5 years relevant experience in biotech/pharmaceutical industry
  • Understanding of the science and technology underlying Drug Substance manufacturing as well as analytical techniques that support commercial manufacturing activities.
  • Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering.
  • Strong knowledge of cGMP requirements. Understanding of the technical aspects of manufacturing, testing, and controls; the regulations governing pharmaceutical operations, as well as financial systems and controls.
  • Experienced utilizing defined methodologies (eg. RCA, risk assessment, process mapping, analytics) to identify, analyze and implement sustainable process improvements.
  • Experience with data analytics and visualization tools; and/or project management collaboration platforms is a plus.
  • Ability to travel globally, as necessary, up to 30%