ARD Director, Small Molecule

NJ Bio; Princeton (NJ); On-site; USD 182,000 - 200,000; Full time

Job summary

NJ Bio, Inc. in Princeton, NJ seeks an ARD Director to lead analytical development activities for small molecule linker payloads, APIs, intermediates, mAbs, proteins, ADCs, and other modalities.

You will develop and qualify analytical methods, shape analytical strategies with clients, and manage a team while ensuring compliance with FDA regulations and SOPs. Travel up to 5% may be required.

Qualifications

• Master’s degree in Chemistry, Pharmaceutical Sciences, or closely related field is required.
• 2+ years of senior-level analytical chemist experience in pharma/biotech.
• Experience with HPLC method development/validation (SEC, RP, IEX, HIC) for large molecules.
• Release/stability testing and method validation per FDA regulations.
• Knowledge of CMC regulatory, Process/Analytical Development, and GMP.

Responsibilities

• Lead analytical method development/qualification for small molecules, APIs, and ADCs in a cGMP environment.
• Manage and develop teams; provide periodic client presentations.
• Collaborate cross-functionally with internal departments and QA on analytical strategies.
• Ensure compliance with FDA regulations and company SOPs.
• Travel to conferences or partner facilities up to 5%.

Skills

HPLC method dev

Method validation

cGMP experience

Large molecule analytics

Education

Master's degree in Chemistry or Pharmaceutical Sciences

Job description

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%.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 085408:00 a.m. to 5:00 p.m.; M-F, $182,000- $200,000.00 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.