Drug Product Manufacturing Associate II - Formulations 1st Shift

Summary

The Drug Product Manufacturing Associate II – Formulations is responsible for implementing and executing routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate II collaborates with the Drug Product team to support the successful completion of various cGMP activities. In this role, the Associate II develops and maintains a strong understanding of both the technical aspects of manufacturing and the quality systems that govern cGMP operations, while contributing to process optimization and continuous improvement.

Responsibilities

• Performs various routine manufacturing tasks in accordance with established Standard Operating Procedures (SOPs) and cGMP regulations.
• Coordinates the implementation of production and manufacturing procedures and schedules.
• Performs visual inspections of tanks and bulk drug substances.
• Prepares components, media, buffers, and other solutions as needed.
• Accurately documents, completes, and reviews batch records.
• Focuses on a variety of manufacturing activities, including sterile filtration, formulation, in-process testing, and preparation of formulation components.
• Performs manufacturing operations within a sterile suite environment.
• Coordinates and leads the preparation of materials and components for sterilization using an autoclave or depyrogenation oven.
• Reliably executes well-defined SOPs.
• Revises SOPs as required based on investigation outcomes or audit findings.
• Collaborates with technical personnel on troubleshooting and engineering activities.
• Collects and disposes of laboratory waste in accordance with established Safety, Health, and Environment (SHE) procedures.
• Performs routine maintenance and troubleshooting of production equipment.
• Maintains a cGMP-compliant environment to support the production needs of the Drug Product group.
• May interact and collaborate with clients and third-party vendors as required.
• Supports the management of group production resources.
• Works closely with the Production Planner to manage QAD work orders and ensure production materials are available according to the manufacturing 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.
• Two to four (2-4) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• 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 scientific or manufacturing environment.
• Familiarity with cGMP, manufacturing, machine operations, and data entry is required.
• Must be familiar with Microsoft Office applications.