Drug Product Manufacturing Associate I - Formulations 2nd Shift

Shift: 2nd. Hours: 2:00PM-10:30 PM

Responsibilities

• Performs various manufacturing tasks, including sterile filtration, formulation, in-process testing, preparation of formulation components, and product development projects, in accordance with established Standard Operations Procedures (SOPs) and cGMP regulations.
• Supports the implementation of manufacturing procedures and production schedules.
• Effectively assists other personnel with technical issues and problems that may arise during the shift.
• Initiates revisions to current Master Batch Records, SOPs, and department desktop aids.
• Supports the maintenance of group production resources and assists with product development projects.
• Expected to operate production equipment, including the TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven, and CIP system.
• Maintains qualification to execute aseptic operations in GMP production facilities comprised of Grade A, B, C, and D manufacturing clean room areas.
• Supports routine maintenance and troubleshooting of production equipment.
• Accurately documents, completes, and reviews batch records, as needed.
• Coordinates and leads preparation of materials and components for sterilization in autoclave or dehydrogenation oven.
• Collaborates with other technical personnel on troubleshooting and engineering activities.
• Collects and disposes of lab waste according to established Safety, Health, and Environment (SHE) procedures.
• Maintains cGMP environment according to the production needs of the Drug Product group.
• May be required to interact and collaborate with clients and third-party vendors.
• Works closely with Production Planner to manage QAD work orders and ensure production materials are obtained according to the manufacturing schedule.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.

Qualifications

• High School Diploma required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
• Minimum of zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
• Familiarity with cGMP, manufacturing, machine operations, and data entry.
• Must be familiar with Microsoft Office applications.