Drug Product Manufacturing Associate I - Formulations

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Drug Product Manufacturing Associate I - Formulations is responsible for the implementation of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements.

The Associate I will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate I will develop a strong understanding of both the technical aspects of the role as well as the quality systems that govern cGMP manufacturing.  
 

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• 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 Service’s cultural values and aligns daily actions with department goals and company culture.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential fun