SR. Manufacturing Manager

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

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 Senior Manufacturing Manager leads all aspects of manufacturing operations, including component preparation, product formulation, aseptic filling, stoppering, capping and lyophilization activities. This role is responsible for overseeing aseptic and non-aseptic operations, ensuring compliance with cGMP regulations, and maintaining sterility assurance across Restricted-Access Barrier Systems (RABS) and other filling technologies.

The Drug Product Senior Manufacturing Manager will also support media fills, aseptic qualifications, regulatory audits, and validation activities, ensuring a controlled and compliant manufacturing environment. Additionally, this role oversees formulation cleaning/decontamination, assembly, sterilization, high-level disinfection, and distribution processes, while managing inventory and supplies to support operational needs.

This position is responsible for budget management, operational efficiency, and cross-functional collaboration, ensuring streamlined production processes while maintaining the highest standards of internal and external customer satisfaction. The Senior Manager will play a critical role in fostering a culture of continuous improvement, sterility assurance, and regulatory readiness to support commercial and clinical manufacturing success.

• Leadership & Operations Management
• Regulatory & Compliance Oversight
• Process Improvement & Validation Support
• Training & Workforce Development
• Facility & Equipment Oversight
• Additional Responsibilities

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The Drug Product Senior Manufacturing Manager will be responsible for overseeing activities and schedules to ensure project timelines are met. This role will also serve as a point of contact for technical discussions with clients, as needed, ensuring alignment on project requirements. Additionally, the role will regularly communicate project status across the organization, collaborating with Manufacturing, Project Management, and the Quality team to ensure seamless execution and compliance.

Responsible for creating and revising SOPs relevant to daily PCI operations to ensure compliance and efficiency. Oversee and direct the activities of Manufacturing Managers, Supervisors, and Technicians, providing guidance and support as needed. Assist in the preparation of staff evaluations, ensuring performance alignment with operational goals. Proactively i dentify and address potential issues, implementing effective solutions to maintain seamless manufacturing operations.

• Expertise in Aseptic Process Development – Strong proficiency in pharmaceutical process development for aseptically produced drug products, including sterile formulation, filling, lyophilization, and packaging.
• Technical Knowledge of Manufacturing Facilities & Equipment – In-depth understanding of pharmaceutical clean rooms, aseptic processing technologies, lyophilization systems, and manufacturing equipment to ensure compliance with cGMP and regulatory expectations.
• Advanced Troubleshooting & Root Cause Analysis – Proven ability to identify, investigate, and resolve complex technical…