Manufacturing Cell culture Specialist

Job Description:
Internal Manufacturing Associate

Location: Onsite

Schedule: Monday–Friday | 40 hours per week

Pay 30-31 per hour.

• Engineering or Life Science Degree
• Cell culture experience
• Effective communication and attention to detail
• Ability to quickly master new tasks and skills.

The Manufacturing Associate will provide execution of upstream manufacturing batch records, and assist in maintaining the suite, supplies and other items. The incumbent will also provide documentation of all activities to meet cGMP requirements.

Responsibilities (include but not limited to):

• Execution of upstream manufacturing batch records for cell culture operations including small-scale media preparation, cell expansion, production, and harvest clarification (including weekend coverage)
• Follow work instructions and/or SOPs, with focus on ‘right the first time’ executions.
• Assist in maintaining suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
• Documentation of all activities to meet cGMP requirements.
• Completes daily record reviews and database maintenance.
• Daily standardization of small equipment and systems
• Maintains the cleanliness of GMP Manufacturing areas by specifications.
• Adheres to all policies and safety guidelines.
• Maintain proper training, documentation, and procedures to support cGMP activities.

Qualifications:

• Requires an A.S. or B.S degree in biological or physical science.
• Experience with sterile transfer technique and mammalian cell culture
• Familiarity with common cell culture equipment including automated cell counters, metabolite analyzers, and bioreactors
• Experience in a GMP regulated environment and an understanding of regulatory/quality requirements for clinical stage manufacturing.