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cGMP Biotech Production Specialist
2 months ago
Randstad, in collaboration with Takeda Pharmaceuticals, is looking for a cGMP Production Specialist to support mRNA Manufacturing operations during the night shift. This position involves 12-hour rotating shifts.
The selected candidate will be an integral part of a dedicated team focused on the production of GMP mRNA-based personalized cancer vaccines intended for human clinical trials. The role requires applying both existing and new knowledge of bioprocess unit operations and current Good Manufacturing Practices (cGMP) to ensure technical success while adhering to a Quality System that meets global regulatory standards. The ideal candidate will possess the ability to document and communicate technical and operational observations effectively.
Compensation: $28 - $29 per hour
Shift: Night
Work Hours: 6 PM - 6 AM
Education Required: High School
Key Responsibilities:
- Perform manufacturing operations utilizing disposable technologies, automation, and Manufacturing Execution Systems (MES) for mRNA production.
- Collaborate closely with Quality Assurance peers for expedited mRNA disposition.
- Exhibit a solid understanding of standard manufacturing practices and equipment.
- Maintain strict compliance with current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and adhere to written procedures for clear and accurate documentation of equipment operation and process instructions, as well as process data.
- Monitor process operations to ensure adherence to specifications.
- Assist in investigating procedural deviations.
- Practice safe work habits and comply with safety procedures and guidelines.
- Utilize expertise to enhance operational efficiency.
- Follow gowning procedures and maintain a clean operating environment.
- Comply with documented waste handling procedures to meet environmental regulations.
Essential Functions:
- Willingness to work up to 8 hours of overtime weekly.
- Availability to work weekends.
Required Skills:
- Biotechnology
- Manufacturing
- Good Manufacturing Practices (GMP)
Qualifications:
- Experience: Minimum of 1 year
- Experience Level: Entry Level
Randstad is a leader in connecting talented individuals with outstanding companies. Our dedicated agents are committed to understanding your employment needs and diligently matching your skills and qualifications with the right opportunities. We offer various employment types, including temporary, temporary-to-permanent, and permanent positions.
Equal Opportunity Employer: We celebrate diversity and are committed to creating an inclusive environment for all employees.
Compensation for successful candidates will be determined based on several factors, including education, work experience, location, specific job duties, and certifications. Randstad also provides a comprehensive benefits package, including health coverage, an incentive and recognition program, and 401K contributions (subject to eligibility).
