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Vice President – Technical Operations
ArvinasSenior executive overseeing Technical Operations for Arvinas, a biotechnology company developing therapies targeting disease-causing proteins. Role emphasizes leadership in CMC activities from preclinical to product launch.
About the role
Key responsibilities & impact- Leadership of the Technical Operations group which incorporates exploratory pharmaceutics, API, DP and Analytical Development, supply chain planning, and CMC authoring.
- Ensuring product supply from pre-clinical development through clinical to commercialization.
- Providing strategic direction and planning of the technical development and manufacturing of clinical/commercial products with attention to quality, robust and reliable supply, cost-effectiveness and efficient scaling.
- Continuing a Technical Operations approach that establishes fast-to-clinic and fast-to-commercial as primary objectives in support of the Arvinas pipeline.
- Responsible for establishing and managing the relationships with contract manufacturers, to assure that commercial and clinical production needs are met cost-effectively and in compliance with all GMP regulations and regulatory standards.
- Establishing partnerships with Discovery, Clinical, Quality, Regulatory and Commercial to ensure a rapid and successful progression of assets to the commercial market.
- Developing and managing annual expense budgets with accurate forecasting based on strategic objectives and prudent decisions regarding expenditures.
- Interfacing with senior management to reach decisions that provide best opportunity for organizational success.
- Leading the compilation and review of technical sections for Module 2/3 in INDs, IMPDs, NDAs, and MAAs.
- Acting as a key executive interface with FDA and EMA for quality sections in INDs, NDAs, IMPDs, and MAAs.
- Building a high performing team ensuring that organizational depth is maintained for all key positions.
Requirements
What you’ll need- A minimum of 20 years experience working within areas of medicinal chemistry, chemical development, pharmaceutical development, and/or analytical development. At least 10 years’ experience in a small/medium biotech environment with substantial CMC area leadership responsibilities.
- Expertise in small molecule synthesis and process development, pre-formulation/formulation development, and analytical development of the same is required.
- Expert-level understanding of API/DP process development and scale-up.
- Expert-level understanding of analytical methods and instrumentation used to characterize reactions, material properties, APIs, and drug products.
- Experience with and understanding Design of Experiments (DOE), Quality by Design (QbD), Process Analytical Technology (PAT), scale up, formulation and process technologies.
- Demonstrated success in advancing a molecule from drug discovery to commercialization.
- Demonstrated success in drafting module 2/3 sections of INDs, IMPDs, NDAs, and MAAs.
- Extensive working knowledge of GxP practices, ICH guidelines, and other regulatory practices as applied to phase-appropriate applications.
- Strong leadership and management abilities.
- Critical analysis and strategic thought embedded within exceptional decision-making abilities.
- Excellent communication, problem-solving and organizational skills applicable in a cross-functional team environment.
- Extensive knowledge of scientific literature and of emerging research areas of pharmaceutical science.
- Arvinas will not be providing VISA sponsorship for this position. You must have the ability to work without a need for a current or future VISA sponsorship.
- The duties of this role are generally conducted in a combination of office, lab and home office environments. Employees must be able, with or without an accommodation to lift/carry 15/30 pounds unassisted/assisted; work comfortable in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
Benefits
Comp & perks- group medical, vision and dental coverage
- group and supplemental life insurance
- competitive package of base and incentive compensation
ATS Keywords
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Hard Skills & Tools
medicinal chemistrychemical developmentpharmaceutical developmentanalytical developmentsmall molecule synthesisprocess developmentpre-formulation developmentformulation developmentanalytical methodsDesign of Experiments (DOE)
Soft Skills
leadershipmanagementcritical analysisstrategic thoughtdecision-makingcommunicationproblem-solvingorganizational skillscollaborationcross-functional teamwork