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Invivyd · 1 day ago

Director, Analytical Development

New Haven, CT

Full-time

Hybrid

Director/Executive

10+ years exp

Invivyd is dedicated to delivering protection from serious viral infectious diseases, including COVID-19. The Director of Analytical Development will provide technical leadership for analytical activities related to monoclonal antibody programs, ensuring alignment with program goals and regulatory requirements.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Analytical developmentProtein-based biologicsRegulatory filingsBiochemistry degreeAnalytical sciencesCommunication skillsCollaboration skillsProject management

Required

Demonstrated and significant experience with analytical development supporting clinical and commercial protein-based biologics, preferably monoclonal antibodies

Advanced degree in Biochemistry or related field

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