[Remote] Vice President, Technical Operations

Note: The job is a remote job and is open to candidates in USA. Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. The Vice President of Technical Operations is responsible for overseeing all CMC activities from preclinical to product launch, leading a Technical Operations group, and ensuring product supply through effective management of development and manufacturing processes.

Responsibilities

• 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

Skills

• 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
• Ph.D. in organic/medicinal chemistry or pharmaceutics. A combination of relevant education, demonstrated subject matter expertise, and applicable job experience may be considered in lieu of the degree

Benefits

• Competitive package of base and incentive compensation
• Comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
• Group medical, vision and dental coverage
• Group and supplemental life insurance

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