Process Development Technician

Alkermes

20d•Onsite

About The Position

Position Summary: The Process Development Technician supports the execution of experimental studies to develop well-understood, robust oral solid dosage (OSD) manufacturing processes. Key responsibilities include equipment setup, cleaning, troubleshooting, execution of experiments, and data collection to identify and implement process and equipment improvements that reduce waste and increase process reliability. This role plays a key part in maintaining GMP standards within the pilot facility and supporting the manufacture of clinical supplies. Responsibilities: Support the set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and technology approaches. Operate, maintain, and troubleshoot a variety of process equipment, rapidly assimilating and applying new technologies as introduced. Perform equipment and room cleaning in compliance with established housekeeping and GMP standards. Assist in designing experimental programs and compiling data from studies. Execute experiments to enhance process understanding and manufacture GMP clinical batches at various scales. Complete all documentation accurately and legibly, ensuring compliance, and participate in updating batch paperwork and SOPs. Maintain a working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required. Maintain awareness of project schedules and strive to achieve whilst responding positively and flexibly to changing priorities to ensure desired outcomes. Assist with root cause investigations and the implementation of CAPAs, as appropriate. Ensure compliance with all applicable cGMP, safety, environmental regulations, and company policies. Take ownership of the general upkeep of process areas and ensure project goals are met. Perform other duties as assigned.

Requirements

Associate’s degree in engineering/scientific discipline, or equivalent, with 1-3+ years of experience in pharmaceutical solid oral dosage processing.
Strong understanding of mechanical and chemical engineering principles as applied to general process systems and oral solid dosage equipment.
Demonstrated hands-on ability to install, operate, and troubleshoot process equipment and instrumentation.
Proficiency with solid oral dosage processing techniques, including powder blending, granulation, compression, coating, and encapsulation.
Working knowledge of data analysis techniques used in process development studies.
Technical problem-solving ability utilizing current research and technologies.
Understanding of the drug development process and the role and impact of process development within this process.
Demonstrated strong people skills, and excellent verbal and written communication skills.
Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.

Responsibilities

Support the set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and technology approaches.
Operate, maintain, and troubleshoot a variety of process equipment, rapidly assimilating and applying new technologies as introduced.
Perform equipment and room cleaning in compliance with established housekeeping and GMP standards.
Assist in designing experimental programs and compiling data from studies.
Execute experiments to enhance process understanding and manufacture GMP clinical batches at various scales.
Complete all documentation accurately and legibly, ensuring compliance, and participate in updating batch paperwork and SOPs.
Maintain a working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required.
Maintain awareness of project schedules and strive to achieve whilst responding positively and flexibly to changing priorities to ensure desired outcomes.
Assist with root cause investigations and the implementation of CAPAs, as appropriate.
Ensure compliance with all applicable cGMP, safety, environmental regulations, and company policies.
Take ownership of the general upkeep of process areas and ensure project goals are met.
Perform other duties as assigned.