Process Development Chemist – API Scale-Up

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 65,000 - 90,000; Full time

Job summary

Abzena is seeking an Associate II to design and conduct research, troubleshoot, and develop scalable synthetic routes for API production, from early development through Phase II trials. You will work with a team to ensure quality, regulatory compliance, and on-time delivery.

The role emphasizes safe handling of high-potency materials, adherence to EHS standards, and thorough record-keeping, with opportunities to contribute to CMC and regulatory activities within a collaborative environment.

Qualifications

• B.S. degree in Chemistry or Chemical Engineering.
• At least three years’ experience as a process research and development chemist in an industry laboratory.
• GMP environment experience preferred.
• Knowledge and experience of analytical techniques and compound characterization.
• Proficiency in MS Office; ERP and ELN systems a plus.

Responsibilities

• Lead development of new processes to manufacture API for early development through Phase II trials.
• Ensure processes are suitable for controlling API quality per cGMP, ICH and FDA regulations and support formulation development.
• Manage chemical process development, kilo-lab and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
• Prepare, purification, and characterization of all materials; maintain laboratory notebooks and records; write reports and SOPs.
• Maintain a safe, clean, and efficient working environment.
• Follow safety procedures for organizational policies and identify optimization opportunities to reduce costs and improve safety.

Education

B.S degree in Chemistry or Chemical Engineering

Tools

MS Office

ERP systems

ELN systems

Job description

Abzena is seeking an Associate II to design and conduct research, troubleshoot, and develop scalable synthetic routes for API production, from early development through Phase II trials. You will work with a team to ensure quality, regulatory compliance, and on-time delivery.

The role emphasizes safe handling of high-potency materials, adherence to EHS standards, and thorough record-keeping, with opportunities to contribute to CMC and regulatory activities within a collaborative environment.