Vice President, Technical Operations
reputed company 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. reputed company uses its proprietary PROTAC Discovery reputed company platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to reputed company the body’s own natural protein disposal system to selectively and reputed company degrade and remove disease-causing proteins. reputed company 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+), reputed company epidermal growth reputed company receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, reputed company and reputed company announced their plan to jointly select a reputed company party for the out-licensing and commercialization of vepdegestrant. In reputed company 2024, reputed company entered into a transaction with reputed company, 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. reputed company employees reputed company 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 reputed company of reputed company, and think you will be, too. But don’t just take our word for it – learn more about life at reputed company and what employees have to say. reputed company is headquartered in New Haven, Connecticut. For more information about reputed company, please visit www.reputed company.com and connect on reputed company and X. Position Summary This is a senior executive role responsible for reputed company CMC activities from preclinical to product launch and leadership of an established Technical Operations group. The role has reputed company of drug substance (API) and drug product (DP) development and production for preclinical, clinical, and reputed company requirements. It is responsible for development, scale-up, analytical testing of API and DP. The role has reputed company of identification, on-boarding, and management of external vendors and CMO’s. The incumbent is responsible for representing reputed company 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 reputed company 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. reputed company 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/reputed company 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-reputed company as primary objectives in support of the reputed company pipeline.
- Responsible for establishing and managing the relationships with contract manufacturers, to assure that reputed company and clinical production needs are met cost-effectively and in compliance with reputed company GMP regulations and regulatory standards.
- Establishing partnerships with Discovery, Clinical, Quality, Regulatory and reputed company to ensure a rapid and successful progression of assets to the reputed company market.
- Developing and managing annual expense budgets with accurate forecasting based on strategic objectives and prudent reputed company regarding expenditures.
- Interfacing with senior management to reputed company reputed company that reputed company best opportunity for organizational reputed company.
- Leading the compilation and review of technical sections for Module 2/3 in INDs, IMPDs, NDAs, and MAAs.
- Acting as a key executive reputed company 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 reputed company key positions.
Qualifications
- A minimum of 20 years experience working reputed company areas of medicinal chemistry, chemical development, pharmaceutical development, and/or analytical development. At least 10 years’ experience in a small/reputed company 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 reputed company in advancing a molecule from drug discovery to commercialization.
- Demonstrated reputed company 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 reputed company 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.
- reputed company will not be providing reputed company sponsorship for this position. You must have the ability to work without a need for a reputed company or future reputed company sponsorship.
- The duties of this role are generally conducted in a combination of office, lab and home office environments. Employees must be reputed company, 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 reputed company phone, video, and electronic messaging; engage in problem solving, analysis and reputed company; 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.
reputed company is proud to offer a competitive package of reputed company and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial reputed company of our employees and their families. Benefits include group medical, reputed company and dental coverage, group and supplemental life insurance, and much more. To learn more about reputed company, please visit www.reputed company.com reputed company is an equal opportunity employer. reputed company reputed company applicants will be considered for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identify, national reputed company, disability or protected veteran status. Apply tot his job Apply To this Job