Vice President, Technical Operations

Arvinas•New Haven, CT

2d•Remote

About The Position

Arvinas is a clinical-stage biotechnology company focused on developing therapies that degrade disease-causing proteins using its proprietary PROTAC Discovery Engine platform. The company is progressing multiple investigational drugs through clinical development for various diseases, including neurodegenerative diseases, cancers, and breast cancer. Arvinas has achieved significant milestones, including FDA acceptance of a New Drug Application for vepdegestrant and strategic transactions with Pfizer and Novartis. The company values its passionate and diverse workforce, encouraging innovation and collaboration. Arvinas is headquartered in New Haven, Connecticut.

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.
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.