Manufacturing Associate – cGMP API Production
About The Position
You will be a key member of a multidisciplinary manufacturing team supporting the cGMP production of non-commercial clinical API batches. This role is hands-on and process-driven, contributing directly to API development by executing batch operations, supporting equipment qualification, and ensuring compliance with cGMP and safety standards. Work is performed in a pilot-scale manufacturing environment with close collaboration across Quality, Compliance, and technical teams. Standard operations involve chemical synthesis of APIs, including solid and liquid handling, distillation, extraction, crystallization, filtration, and drying.
Requirements
- High School Diploma or GED required
- 4+ years of relevant manufacturing experience
- Demonstrated experience in a cGMP pharmaceutical manufacturing environment
- Working knowledge of Production Control Systems
- Strong troubleshooting, problem-solving, and critical-thinking skills
- Ability to work independently while contributing effectively within a matrix team
- Strong organizational skills, attention to detail, and follow-through
- Physically capable of: Standing for extended periods, Lifting ≥50 lbs, Wearing PPE and working with hazardous materials
- Excellent written and verbal communication skills
- Proficient in Microsoft Office (Word, Excel)
- Authorization to work in the United States indefinitely without restriction or sponsorship
Nice To Haves
- Associate degree in a scientific or technical discipline
- Strong mechanical aptitude with a hands-on mindset
- Experience with DeltaV Production Control System
- Experience supporting API manufacturing in a cGMP environment
- Hands-on experience with large-scale distillation, filtration, drying, or milling operations
Responsibilities
- Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment.
- Prepare, operate, monitor, sample, and clean complex pharmaceutical manufacturing equipment according to SOPs.
- Perform hands-on chemical processing activities, including: Solid and liquid charging, Atmospheric and vacuum distillation, Liquid-liquid extractions and phase separations, Crystallization, filtration, milling, and drying.
- Perform routine manual material handling, including lifting and moving loads ≥50 lbs using proper safety techniques.
- Identify, troubleshoot, and resolve equipment and process issues.
- Generate, review, and execute cGMP documentation such as: Batch records, Cleaning records, In-process control sampling documentation.
- Support equipment commissioning and qualification activities.
- Participate in SOP periodic reviews.
- Report deviations, observations, or safety concerns that may impact product quality or process safety.
- Ensure proper handling, segregation, and disposal of manufacturing waste in compliance with environmental and safety requirements.
- Communicate effectively across cross-functional teams including Quality, Compliance, Process Chemists, Analysts, and Supervisors.
- Actively participate in shift handovers and operational communications.
- Identify and implement continuous improvement opportunities.
- Prioritize personal workload and support less-experienced colleagues in task planning and execution.
- Complete required training and participate in facility safety inspections.
Benefits
- Comprehensive medical coverage
- Dental options
- Vision options
- Life insurance
- Disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
