Process Development Technician
Alkermes
5 months ago
On-site
Greater Boston
Operations
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; participate in updating batch paperwork and SOPs.
- Maintain working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required.
- Maintain awareness of project schedules and respond positively and flexibly to changing priorities.
- Assist with root cause investigations and implementation of CAPAs, as appropriate.
- Ensure compliance with applicable cGMP, safety, and 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.
Qualifications/Requirements:
- Associate’s degree in engineering/scientific discipline (or equivalent) with 1–3+ years of experience in pharmaceutical solid oral dosage processing.
- Proficiency with solid oral dosage processing (powder blending, granulation, compression, coating, encapsulation).
- Strong understanding of mechanical and chemical engineering principles for process systems and OSD equipment.
- Hands-on ability to install, operate, and troubleshoot process equipment and instrumentation.
- Working knowledge of data analysis techniques for process development studies.
- Technical problem-solving using current research and technologies.
- Understanding of the drug development process and the role/impact of process development.
- Strong verbal and written communication skills; demonstrated people skills.
- Understanding of ICH, FDA, and USP guidelines and ability to apply them to the drug development stage.
- Ability to work in a fast-paced team/matrix environment and independently manage priorities and timelines.
Compensation/Benefits (if provided in posting):
- Annual base salary: $77,000–$83,000.
- Eligible for an annual performance pay bonus.
- Competitive benefits package (details on www.alkermes.com/careers#working-here).
- 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; participate in updating batch paperwork and SOPs.
- Maintain working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required.
- Maintain awareness of project schedules and respond positively and flexibly to changing priorities.
- Assist with root cause investigations and implementation of CAPAs, as appropriate.
- Ensure compliance with applicable cGMP, safety, and 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.
Qualifications/Requirements:
- Associate’s degree in engineering/scientific discipline (or equivalent) with 1–3+ years of experience in pharmaceutical solid oral dosage processing.
- Proficiency with solid oral dosage processing (powder blending, granulation, compression, coating, encapsulation).
- Strong understanding of mechanical and chemical engineering principles for process systems and OSD equipment.
- Hands-on ability to install, operate, and troubleshoot process equipment and instrumentation.
- Working knowledge of data analysis techniques for process development studies.
- Technical problem-solving using current research and technologies.
- Understanding of the drug development process and the role/impact of process development.
- Strong verbal and written communication skills; demonstrated people skills.
- Understanding of ICH, FDA, and USP guidelines and ability to apply them to the drug development stage.
- Ability to work in a fast-paced team/matrix environment and independently manage priorities and timelines.
Compensation/Benefits (if provided in posting):
- Annual base salary: $77,000–$83,000.
- Eligible for an annual performance pay bonus.
- Competitive benefits package (details on www.alkermes.com/careers#working-here).