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Arvinas

Vice President, Technical Operations

Reposted 3 Days Ago
Be an Early Applicant
Remote or Hybrid
Hiring Remotely in New Haven, CT
Expert/Leader
Remote or Hybrid
Hiring Remotely in New Haven, CT
Expert/Leader
Lead CMC activities from preclinical to product launch, managing Technical Operations, overseeing drug development and production, and ensuring regulatory compliance while building relationships with stakeholders and vendors.
The summary above was generated by AI

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-102, targeting LRRK2 for neurodegenerative diseases; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic, colorectal, and non-small cell lung cancers; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle; and vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer.

On August 8th 2025, the U.S. Food and Drug Administration (FDA)  accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.


Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, please visit www.arvinas.com and connect on LinkedIn and X.


Position Summary

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.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

  • 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.

  • 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.

EDUCATION

  • 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.

#LI-Remote

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status. 



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