Manager, Manufacturing

PCI Pharma Services; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our location, overseeing aseptic and non-aseptic processes, lyophilization, and related activities. You will manage staff, schedules, budgets, and cross-functional collaboration with Quality, Validation, Facilities, and Project Management to deliver compliant, efficient production.

The role requires a BA in science and at least 5 years of pharma or medical device manufacturing leadership,

Qualifications

• Aseptic process leadership and strong understanding of cGMP in pharmaceutical/medical device environments.
• Experience coordinating cross-functional teams to drive compliant manufacturing.
• Ability to manage schedules, budgets and staff across complex operations.

Responsibilities

• 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
• TRAVEL - <10%

Skills

Aseptic process leadership

cGMP knowledge

Project management

Staff leadership

Education

BA science degree, or equivalent

Job description

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.

The Manufacturing Manager 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

Special Demands

• Ability to stand, sit or remain in the same position for extended periods of time
• May be required to travel between sites
• Follow written instructions
• Able to train others
• Able to work in a highly complex environment with competing demands and priorities

Work Environment

• Proficiency in pharmaceutical process development for aseptically produced products or medical device manufacture
• Working knowledge of pharmaceutical facilities, lyophilization technology and manufacturing equipment as well as cleanrooms
• Strong troubleshooting and root cause analysis skills
• Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively
• Able to effectively deal with complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff
• Excellent oral and written (reports) communication skills
• Strong organization and leadership skills
• Self-motivated with a drive for excellence; able to inspire and motivate the staff
• Honesty, integrity, respect and courtesy with all colleagues
• Creative and can work with minimal supervision following internal procedures balanced with independent thinking
• Resilient through operational and organizational change
• Strong commitment to excellence and quality with a positive working attitude
• This Manager will be responsible for the activities and schedules to meet designated timelines as well as communicating with the clients on technical aspects of the project, if needed. Additionally, this Manager will be responsible for communicating the status of the project with the rest of the organization including Manufacturing, Project Management, and the entire Quality team.
• Responsible for revising and creating SOP’s pertinent to daily tasks in PCI operations. Responsible for directing activities of Manufacturing Technicians. Assist in the preparation of staff evaluations. Must be able to observe and identify potential issues and address satisfactorily.
• TRAVEL - <10%

Qualifications

• BA science degree, or equivalent
• A minimum of 5 years relevant pharmaceuticalor medical device manufacturing experience
• Proven aseptic process leadership experience
• Must understand cGMP and WW regulatory requirements (e.g. EU) for parentals or familiar with working in ISO 5 and 6 areas. Gowning experience necessary.
• Understanding of basic contamination and aseptic technique and any formal training would be beneficial.

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.