Manager, Pharmaceutical Operations

PCI Pharma Services Manager, Pharmaceutical Operations

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.

Summary of Objective : The Manager, Pharmaceutical Operations leads all aspects of manufacturing operations per assigned location and product type. Managers may work in medical device manufacturing or may support the manufacturing of drug products. The Manager may support aseptic, non-aseptic operation activities as well as lyophilization activities. As assigned, the manufacturing manager will be responsible for activities such as component preparation, product formulation, aseptic filling, stoppering, capping and lyophilization activities. The incumbent is also expected to support media fill activities and aseptic qualifications, audits, validation assistance, and the ability to maintain a cGMP environment, as well as participate in responses to internal and external audits. Manage formulation cleaning / decontamination, assembly, sterilization, high-level disinfection and distribution. Manages inventory and supplies supporting departmental activities. The manager is also tasked with developing and ensuring compliance with departmental budget, and to work collaboratively with other departments to create and ensure process and cost efficiencies. Excels in customer service, ensuring the highest standards for both internal and external customer satisfaction.

Essential Duties and Responsibilities :

• Responsible for managing and directing staff to ensure proper and continuous function of all manufacturing operations and adherence to the established schedules
• Leads the safety initiatives for manufacturing and ensure department compliance with all PCI safety procedures, processes.
• Ensures that all operations of the drug / product cleanroom areas are being performed in accordance with cGMP and current regulatory guidelines as well as all applicable SOPs
• Supports the production schedule to meet requirements for staffing, work schedules, planning activities, and equipment maintenance
• Directs personnel to complete and review all associated batch record and SOP documentation
• Writes, reviews / approves investigation, OOT / OOS, EEIs and completion of deviation reports
• Writes, reviews / approves change control orders and CAPAs
• Coordinates assistance for Validation protocols, and other process studies. Coordinates activities for process enhancement projects and supports new product development projects
• Ensures training of operators to learn techniques for product formulation, preparation of materials / products, aseptic technique, contamination control, gowning, , labeling and packaging
• Oversees control of product manufacturing operation areas including cleanrooms, component prep and sanitization, filling, and packaging activities
• Works closely with Validations, Facilities, Quality, Project Management and Senior Management to ensure the needs of all functions are met
• Other duties as assigned, or as business needs require

Work Environment :

Qualifications :

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.

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer / Vet / Disabled