Temp-Process Development Technician-OSD

Alkermes • Wilmington, OH

23h

About The Position

The Process Development Technician supports the execution of experimental and clinical studies to develop well-understood, robust oral solid dosage (OSD) manufacturing processes. Key responsibilities include execution of experiments, documentation and data collection to support process development. This role plays a key part in maintaining GMP standards and supporting the manufacture of development and clinical supplies.

Requirements

• Associate or bachelor’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.
• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree