Role: Manufacturing Associate II – (GMP)

Location: Harmans, MD

Duration: 3-6 months

What You'll Do:

• Execute and document manufacturing operations per SOPs and Batch Production Records (BPRs)
• Troubleshoot equipment/process issues and collaborate with Facilities/Validation teams
• Support deviation investigations, CAPAs, and process improvements
• Assist in tech transfer and onboarding of new GMP projects
• Generate and revise SOPs, BPRs, and other GMP documents
• Interact with clients during manufacturing campaigns; may escort person-in-plant (PIP)
• Participate in facility expansions, equipment validation, and cross-functional collaborations

What we are looking for:

• HS diploma + 4–7 yrs, Associate’s + 2–4 yrs, or Bachelor’s + 1–3 yrs in GMP biologics manufacturing (upstream or downstream)
• Strong knowledge of cGMP, manufacturing principles, and documentation standards
• Excellent communication, teamwork, and problem-solving skills
• Able to lift up to 40 lbs., stand/walk frequently, and work shifts/weekends as needed