Manufacturing Associate II

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.
• Is fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
• Other duties as assigned.

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.

Job Types: Full-time, Contract

Pay: $29.80 - $32.89 per hour

Schedule:

• 12 hour shift
• Day shift
• Overnight shift
• Rotating shift

Experience:

• Pharmaceutical Manufacturing: 4 years (Preferred)
• upstream (fermentation/bioreactor): 4 years (Preferred)
• or downstream (column chromatography, buffer/media): 4 years (Preferred)

Shift availability:

• Day Shift (Preferred)
• Overnight Shift (Preferred)

Ability to Relocate:

• Harmans, MD: Relocate before starting work (Required)

Work Location: On the road

Salary : $30 - $33