*** 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)
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.
- 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%