Manufacturing Associates (Levels I, II, and III) for a Drug Product Team, specializing in the aseptic filling and packaging of biologic products in a controlled, cGMP-compliant environment. Manufacturing Associates will play a critical role in ensuring the successful production of sterile drug products by performing operations that include material preparation, aseptic filling, equipment setup, and final packaging.
Key Responsibilities
- Manufacturing Associate I: Support routine aseptic filling and packaging operations, assist with equipment setup and cleaning, monitor quality through visual inspections, and document activities following SOPs.
- Manufacturing Associate II: Independently execute and monitor aseptic processes, lead equipment setup and minor maintenance, ensure documentation accuracy, and mentor junior associates.
- Manufacturing Associate III: Lead and oversee aseptic operations, resolve technical and operational challenges, drive process improvements, and train team members while supporting audits and validation activities.
Qualifications
- Level I: High school diploma or equivalent; 0–1 year of GMP experience; knowledge of aseptic techniques is a plus.
- Level II: Associate/Bachelor's degree preferred; 1–3 years of aseptic GMP experience; proficiency with sterile equipment.
- Level III: Bachelor's degree preferred; 3+ years in aseptic manufacturing with leadership experience and expertise in GMP compliance.
