The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required.
KEY RESPONSIBILITIES:
Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
Generate and revise internal and external documents (SOPs, BRs)
Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
Recommend equipment and other supply purchases within the production areas
Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions.
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
Work closely with various departments and aid other teams as necessary
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
Participate in facility expansion and equipment validation activities
Education & Experience:
HS or GED with 4-7 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
OR
Associate's degree in a Scientific, Engineering or Biotech field with 2-4 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
OR
Bachelor's degree in a Scientific, Engineering or Biotech field with 1-3 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
Thorough knowledge of current Good Manufacturing Practices (cGMP's), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.