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Arvinas · 4 days ago

Senior Director, External API Manufacturing and Supply

United States

Full-time

Remote

Director/Executive

15+ years exp

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating diseases through innovative therapies. The Senior Director, External API Manufacturing and Supply will be responsible for overseeing the API supply chain strategy, managing relationships with CDMOs, and ensuring compliance with quality and regulatory requirements throughout the drug development process.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

No H1B

Responsibilities

Design and implement a comprehensive API supply chain strategy for specific projects at Arvinas

Working with Process R&D, craft and distribute request-for-proposals to CDMOs to access intermediates and API supplies to enable the Arvinas pipeline

Evaluate proposals and quotes matching the capabilities of the supplier with the project requirements in terms of quantity, quality, and timing of deliverables

Working with Process R&D select the best providers of service to meet project needs

Working with internal and external legal resources craft master service agreements and contracts to reflect required deliverables

As the primary contact with the contractors, manage day-today interactions to ensure that deliverables are completed as contracted

Contribute to technical oversight of contracted suppliers in execution of API-related deliverables

Drive forecast planning and inventory management of project intermediates and APIs to meet near-term and long-term goals. Incorporate risk-mitigation strategies

Participate in budget-planning for API campaigns and track all spend relative to budget

Communicate production schedules to Project Management and the project team as part of project Integrated Development Plans for specific Arvinas assets

Manage the CMC API Supply Chain interfaces with Drug Product Supply, Quality Assurance, and Regulatory Compliance

Establish detailed plans to guide project chemical development activities from early development to commercialization, ensuring all quality and regulatory requirements are proactively satisfied

Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes

Lead the collection of relevant data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments

Qualification

API development managementCGMP knowledgeRFP/contracting processInventory managementProject managementMulti-taskingProactive issue identificationMS Office proficiencyProblem-solvingCommunication skillsLeadership skillsNegotiation skillsPresentation skillsDetail-orientedCross-functional collaborationOrganizational skills

Required

A successful history of hands-on chemical development and scale-up

A successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors

Experience with management of all stages of API development and manufacturing

Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to manufacture and quality testing of pharmaceutical products

Demonstrated experience in inventory management and forecasting

Ability to effectively prioritize and deliver on tight timelines

Outstanding problem-solving abilities

Detail-oriented, with good organizational and project management skills

Good oral and written communications skills

Proficient with MS Word, PowerPoint, Excel

Strong leadership, project planning, negotiation and presentation skills

Significant experience in communicating/presenting complex information to senior management and regulatory agencies

Ability to multi-task and manage several projects in parallel, paying attention to detail

Ability to forge cross-functional working relationships with internal and external project partners

Ability to be proactive in identifying issues and hurdles that may hinder the effective progression of an asset and resolve the issues in a timely and creative fashion

Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future

An MS/Ph.D in Chemistry or Chemical Engineering or related technical field and 15+ years relevant experience in CMC operational roles, preferably in a bio-tech environment