[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 Company Overview Arvinas advances therapies degrading disease-causing proteins for life-threatening diseases, from discovery to commercialization. It was founded in 2013, and is headquartered in New Haven, Connecticut, USA, with a workforce of 201-500 employees. Its website is http//www.arvinas.com.