Vice President, Technical Operations

Arvinas•New Haven, CT

3d•Hybrid

About The Position

This is a senior executive role responsible for all CMC activities from preclinical to product launch and leadership of an established Technical Operations group. The role has oversight of drug substance (API) and drug product (DP) development and production for preclinical, clinical, and commercial requirements. It is responsible for development, scale-up, analytical testing of API and DP. The role has oversight of identification, on-boarding, and management of external vendors and CMO’s. The incumbent is responsible for representing Arvinas CMC function in meetings with regulatory authorities and review of CMC documentation consistent with relevant regulations and guidelines. The role is responsible for higher level integration of Technical Operations activities with key stake holders such as discovery chemistry, quality, clinical, and regulatory groups. This role is a key member of the Executive Committee Portfolio team, Development Governance, and reports to the Chief Financial Officer. The role can be remote, hybrid, or located at our headquarters in New Haven, CT.

Requirements

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.
You must have the ability to work without a need for a current or future VISA sponsorship.

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.