*** 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%
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