GMP Biologics Manufacturing Associate II (Day Shift)

Catalent, Inc.; United States; On-site; USD 46,000 - 53,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off + 8 holidays

Job summary

Catalent, Inc. is seeking an Associate II, Manufacturing for its FDA-licensed Harmans/BWI campus in Maryland. The role supports GMP upstream or downstream biologic production and ensures compliance across Phase I/II and commercial manufacturing.

The position offers a day shift (7am–7pm) on a 2-2-3 rotation, onsite at Harmans, MD. You will work with multiple teams to transfer projects into GMP and maintain rigorous documentation.

Qualifications

• High School diploma or GED with 4+ years GMP upstream or downstream biologic production experience.
• Associate's degree with 2+ years GMP bioproduction experience.
• Bachelor's degree with 1+ years GMP bioproduction experience.
• Strong knowledge to apply scientific principles to solve operational tasks.
• Excellent documentation skills including batch records, SOPs, deviations, and summaries.

Responsibilities

• Complete Batch Production Records under GMP and document processes.
• Generate operational protocols and batch records, deviations, and reports.
• Collaborate with Process Development and Manufacturing Sciences to transfer projects into GMP.
• Generate and revise internal/external SOPs and Batch Records.
• Support deviations; may lead investigations and CAPAs.
• Troubleshoot process/equipment issues; coordinate with Facilities/Validation.

Skills

GMP knowledge

Documentation skills

Team collaboration

English communication

Flexible scheduling

Problem solving

Education

High School Diploma + 4+ years GMP experience

Associate's degree in Scientific/Engineering/Biotech

Bachelor's degree in Scientific/Engineering/Biotech

Job description

Catalent, Inc. is seeking an Associate II, Manufacturing for its FDA-licensed Harmans/BWI campus in Maryland. The role supports GMP upstream or downstream biologic production and ensures compliance across Phase I/II and commercial manufacturing.

The position offers a day shift (7am–7pm) on a 2-2-3 rotation, onsite at Harmans, MD. You will work with multiple teams to transfer projects into GMP and maintain rigorous documentation.