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.

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

Requirements:

• Demonstrated and significant experience with analytical development supporting clinical and commercial protein-based biologics, preferably monoclonal antibodies
  • Preference given to candidates with late clinical stage development experience
• 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

#LI-Hybrid