Drug Product Manufacturing Associate - Formulations 1st Shift

Position: Drug Product Manufacturing Associate I - Formulations 1st Shift
## Drug Product Manufacturing Associate I - Formulations 1st Shift Apply:
San Diego, CA, USA:
Full time:
Posted Yesterday:
JR119874

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** 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.
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* Summary:

** 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.

** Shift: 1st Shift
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* Hours:

8AM - 5PM
**** Responsibilities:
** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential 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 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
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* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with…