ARD Director, Molecule

Job Details:

Job Location:

Headquarters
- New Jersey - PRINCETON, NJ 08540, Salary Range: $ - $ Salary/year, ARD Director, Small Molecule wanted in Princeton, New Jersey to lead the analytical development activities of client projects including small molecule linker payload, APIs, intermediates, monoclonal antibodies, proteins, antibody drug conjugates and other therapeutic modalities.

Duties include:

Responsible for analytical method development/qualification, product characterization, leading the teams, preparing the presentation for the client meetings and supporting the management team in other activities as needed; contribute to setting analytical strategy, working with clients on analytical work strategies, and in partnership with internal and external Quality colleagues to play key role in the development;
Work cross-functionally with internal departments and external resources on Analytical Research & Development related issues;
Manage direct reports; and Ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Travel to conferences, partner facilities, or other company facilities required as needed or up to 5%.

Requirements::
Master’s degree (or foreign equivalent) in Chemistry, Pharmaceutical Sciences, or a closely related field. Requires 2 years of senior-level experience as an analytical chemist or related role in the pharmaceutical or biotechnology industry. Experience must include each of the following: developing, optimizing, troubleshooting, qualifying, and validating HPLC methods (SEC, RP, IEX, HIC etc.) for large molecules characterization in cGMP environment;

release/stability testing and method development/validation for assay and related substance tests as per FDA regulations; control strategy for large molecules, drug substance and drug products, and phase appropriate method qualifications; and early- and late-stage development of ADC products, including CMC regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.

Work location:

350 Carter Road, Princeton, NJ 08540

8:00 a.m. to 5:00 p.m.; M-F, $182,000- $ per year.

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.