ARD Director, Small Molecule

NJ BIO INC • Princeton, NJ

1d • $182,000 - $200,000 • Onsite

About The Position

NJ Bio, Inc. is seeking an ARD Director, Small Molecule to lead analytical development activities for client projects involving small molecule linker payloads, APIs, intermediates, monoclonal antibodies, proteins, antibody drug conjugates, and other therapeutic modalities. The role is based at the company’s Princeton, New Jersey headquarters and is scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m. Travel to conferences, partner facilities, or other company facilities may be required as needed, up to 5%.

Requirements

• Master’s degree or foreign equivalent in Chemistry, Pharmaceutical Sciences, or a closely related field.
• At least 2 years of senior-level experience as an analytical chemist or in a related role in the pharmaceutical or biotechnology industry.
• Experience developing, optimizing, troubleshooting, qualifying, and validating HPLC methods (including SEC, RP, IEX, and HIC) for large-molecule characterization in a cGMP environment.
• Experience with release and stability testing and method development and validation for assay and related-substance tests under FDA regulations.
• Experience with control strategies for large molecules, drug substances, and drug products, and phase-appropriate method qualifications.
• Experience in early- and late-stage development of ADC products, including CMC regulatory work, Process/Analytical Development, GMP Manufacturing, and QC release and stability testing.

Responsibilities

• Lead analytical development activities for client projects involving a range of therapeutic modalities.
• Oversee analytical method development and qualification and product characterization.
• Lead teams, prepare presentations for client meetings, and support the management team in other activities as needed.
• Contribute to analytical strategy and work with clients to develop analytical work strategies.
• Partner with internal and external Quality colleagues in development activities.
• Work cross-functionally with internal departments and external resources on Analytical Research & Development issues.
• Manage direct reports.
• Ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.

What This Job Offers

• Job Type: Full-time
• Career Level: Director