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.

This position will have the primary responsibility for daily formulation activities to ensure scheduled activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company.

Essential Duties and 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.

• Maintains and adheres to safe work habits and all applicable PCI PHARMA SERVICES safety procedures and guidelines
• Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed
• Performs critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss with minimum to no supervision.
• Initiate the production of batch documentation used for engineering and cGMP production.
• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
• Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes
• Completes Batch Records accurately and completely prior to submission to supervision for review
• Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
• Initiate quality system events when these occur within the department
• Cross train in the Fill department to increase technical skills including but not limited to Fill/Cap in room 148
• Able to complete prep work, including operation of autoclave and depyrogenation oven
• Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements.
• Complete gowning qualification to perform aseptic operations in the manufacturing area
• Work with enabling groups to improve/implement processes.
• Other duties as assigned.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Able to stand for long periods of time, the majority of the work shift
• Able to lift 30lbs repeatedly
• Able to wear PPE (mask, gloves, respiratory)

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.

• High school Diploma, GED, or equivalent credential required; AS degree or BS degree in a STEM field (Science, Technology, Engineering, or Mathematics), such as Computer Science, Engineering, Mathematics, Physics, or a related discipline is preferred.
• • Minimum 1-3 year’s work experience in a GMP environment preferably in fill finish pharmaceutical operations; equivalent combination of education and experience will be considered.
• Experience and knowledge of formulation/compounding tools and equipment
• Demonstrated ability to prioritize multiple projects and activities
• Strong interpersonal skills
• Strong working knowledge of MS Office suite is preferable
• Strong communication skills
• Attention to detail and positive attitude are key attributes
• Able to follow rules and regulations perfectly
• Resilient as well as flexible

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.