Vice President, Technical Operations

Principal 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.

Qualifications

• 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.