Manufacturing Associate / Senior Manufacturing Specialist
- Formulation and fill/finish of drug products for clinical trials.
- Maintenance of cGMP manufacturing facility, including cleaning of equipment and manufacturing cleanrooms.
- Write and/or revise cGMP documents related to technology transfer and production and materials management (SOP's, CAPA's, IQ/OQ/PQ's, etc.)
- Remain on-call after hours (on rotating basis) to monitor and respond to equipment alarms as needed.
- Participate in implementing process improvements and corrective actions.
- Manage inventory for cGMP manufacturing including ordering and vendor management.
- Shipping and receiving of GMP/clinical materials.
- BA/BS or equivalent in a biological science, chemistry, or 5 years’ experience in cGMP drug product manufacturing environment.
- Experience with fill and finish operations for small volume parenterals desired.
- Ability to follow cGMP regulations and industry standards for production of sterile drug products.
- Experience with cGMP qualifications/validations (IQ/OQ/PQ) of facilities, equipment, and manufacturing processes desired.
- Experience with pharmaceutical inventory/supply chain management desired.
- Must be motivated, able to follow written or verbal direction and work under minimal supervision, and willing to perform hands-on operations of production activities.