Director, Analytical Development

Invivyd, Inc.•New Haven, CT

5d•Hybrid

About The Position

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers. At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024 , Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. In October 2025 , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: New Haven, CT (Northeast Preferred) This position is hybrid and requires travel to New Haven, CT HQ at least once a month. Position Summary: The position is responsible for technical leadership of analytical development within the CMC function across Invivyd's portfolio. Analytical Development has responsibility for analytical activities (e.g. method development, characterization, structure/function, comparability) from late-stage Discovery through commercial life cycle for monoclonal antibody programs. The candidate will ensure success on all deliverables by leveraging internal and external resources. They will also be responsible for strategic and scientific alignment of analytical development activities with overall program goals.

Requirements

Demonstrated and significant experience with analytical development supporting clinical and commercial protein-based biologics, preferably monoclonal antibodies
Advanced degree in Biochemistry or related field, PhD preferred
10+ years of relevant analytical experience for biologics in the pharmaceutical industry including significant experience with regulatory filings
Broad understanding of analytical sciences and regulatory/GMP requirements
Proven track record in analytical development for clinical stage and commercial programs
Excellent communication and collaboration skills in a cross-functional and fast-paced environment
Proven ability to achieve results with external laboratories and manufacturing facilities
Ability to travel to New Haven at least once a month

Nice To Haves

Preference given to candidates with late clinical stage development experience

Responsibilities

Technical lead of analytical method development for Invivyd programs; serve as analytical lead on development teams
Lead the development of platform methods that are fit-for-purpose to support the requirements of early-stage development, progression into the clinic, and commercial lifecycle
Drive regulatory strategy regarding characterization, analytical comparability, and stability studies and support execution
Manage review of raw data packages associated with method qualifications/validations, release testing, stability testing, and characterization testing of drug substances and drug products
Contribute to the analytical control strategy for drug substance and drug product
Support process characterization and process validation
Develop and ensure the delivery of high-quality documentation to meet global regulatory expectations for analytical methods and Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications
Oversee relevant vendors (CMOs/CTLs) during the development and characterization of drug substance and drug product. Travel to CMOs and CTLs as needed
Effectively collaborate with and provide technical support to the fully integrated CMC and development teams
Apply technical and management expertise to meet project goals and timelines; make technical and management decisions to keep projects on track