Director, Analytical Development

ABOUT US

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. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.

Be part of making a difference. Be part of Invivyd.

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:

The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements as well as a 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 as well as a proven ability to achieve results with external laboratories and manufacturing facilities are a must. Other requirements include:

• 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.

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies.