Senior Scientist - Parenteral Formulation

American Regent; New Albany (OH); On-site; USD 130,000 - 190,000; Full time

Job summary

American Regent is seeking a senior scientist for parenteral drug product development. You will design and execute parenteral formulation studies, align with QbD principles, and develop scalable processes for sterile injectables.

The role includes technology transfer, regulatory interactions, and training of lab personnel to ensure GMP compliance. The candidate will draft development reports and support NDA/ANDA submissions, while collaborating across teams to troubleshoot manufacturing issues

Qualifications

• Requires PhD or MS with extensive pharmaceutical drug product development experience.
• In-depth knowledge of formulation development following QbD principles.
• Experience with sterile injectable products, suspension and freeze-dried formulations is a plus.
• Hands-on skills with analytical instruments (HPLC, Karl Fischer) are preferred.
• Experience in scale-up, tech transfer and regulatory interactions is expected.

Responsibilities

• Design and implement parenteral formulation studies per FDA/ICH guidance.
• Develop scalable manufacturing processes for parenteral products.
• Draft raw material specifications and R&D reports for regulatory submissions.
• Train laboratory personnel and ensure compliance with GMP and safety policies.
• Support regulatory responses to FDA deficiencies and conduct literature searches.

Skills

QbD principles

Formulation development

Sterile injectables

Process development

Regulatory knowledge

Team collaboration

Education

PhD in Pharmaceutical Sciences

MS in Pharmaceutical Drug Product Development

Tools

HPLC

Karl Fischer titrator

Particle size analyzer

Job description

American Regent is seeking a senior scientist for parenteral drug product development. You will design and execute parenteral formulation studies, align with QbD principles, and develop scalable processes for sterile injectables.

The role includes technology transfer, regulatory interactions, and training of lab personnel to ensure GMP compliance. The candidate will draft development reports and support NDA/ANDA submissions, while collaborating across teams to troubleshoot manufacturing issues