SR. Manufacturing Manager

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Summary of Objective:

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.

Essential Duties and Responsibilities:

• Leadership & Operations Management

  • Manage and direct manufacturing staff to ensure continuous operation of aseptic and non-aseptic manufacturing processes while adhering to established production schedules.

  • Ensure that all activities within drug product cleanroom areas are performed in compliance with cGMP regulations, regulatory guidelines, and internal SOPs.

  • Support the production schedule by coordinating staffing, work schedules, planning activities, and equipment maintenance to meet manufacturing demands.

• Regulatory & Compliance Oversight

  • Ensure all batch record documentation, SOPs, and associated manufacturing records are accurately completed and reviewed by personnel.

  • Author, review, and approve investigations, Out of Trend (OOT)/Out of Specification (OOS) reports, Exception Event Investigations (EEIs), and deviation reports to ensure timely resolution.

  • Write, review, and approve change controls and CAPAs to support continuous improvement and compliance initiatives.

• Process Improvement & Validation Support

  • Coordinate activities related to validation protocols, process studies, and process enhancement projects to optimize manufacturing efficiency and compliance.

  • Collaborate with cross-functional teams on new product introductions, technology transfers, and manufacturing process optimizations.

• Training & Workforce Development

  • Oversee training and qualification programs for operators in product formulation, material preparation, aseptic technique, contamination control, gowning, labeling, and packaging.

  • Ensure operators are proficient in sterility assurance principles and regulatory expectations for aseptic processing.

• Facility & Equipment Oversight

  • Manage and maintain control over manufacturing operations, including cleanrooms, component preparation, sanitization, filling, and packaging activities.

  • Work closely with Validation, Facilities, Quality, and Project Management teams to ensure operational efficiency and regulatory readiness.

• Additional Responsibilities

  • Support audits and regulatory inspections by ensuring readiness, supporting facility tours, and adherence to compliance standards.

  • Execute other duties as assigned or as business needs require.

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 identify and address potential issues, implementing effective solutions to maintain seamless manufacturing operations.

Qualifications:

• 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 cleanrooms, 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 issues using structured problem-solving methodologies such as Root Cause Analysis (RCA) and CAPA.

• Project & Resource Management - Skilled in leading and coordinating multiple, complex projects, ensuring efficient resource allocation and execution while maintaining operational priorities.

• Analytical & Decision-Making Skills - Ability to navigate complex technical challenges, apply structured analysis methodologies, and provide clear, actionable guidance to manufacturing and support teams.

• Effective Communication - Strong oral and written communication skills, with the ability to prepare clear, concise reports and articulate technical concepts to cross-functional teams and senior leadership.

• Leadership & Organizational Excellence - Proven ability to lead teams, drive accountability, and foster a culture of continuous improvement, ensuring operational efficiency and regulatory compliance.

• BA science degree, or equivalent

• A minimum of 7-10 years' experience leading pharmaceutical production operations for aseptic formulations, filling and lyophilization;

• Minimum 7 years' experience in a GMP environment.

• Driven & Inspirational Leader - Self-motivated with a commitment to excellence, capable of inspiring and motivating teams to achieve operational success.

• Integrity & Professionalism - Demonstrates honesty, respect, and courtesy in all interactions, fostering a collaborative and ethical work environment.

• Innovative & Independent Thinker - Able to balance adherence to internal procedures with independent problem-solving, bringing creativity to operational challenges.

• Resilient & Adaptable - Maintains focus and effectiveness through operational and organizational changes, ensuring continuity and performance under evolving conditions.

• Commitment to Quality & Excellence - Embodies a positive attitude, strong work ethic, and dedication to delivering high-quality results in all aspects of aseptic operations.

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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.