The Associate Director, Manufacturing Operations will provide leadership and management of operations at the Horsham, PA site, including but not limited to the following functional areas: Bulk drug substance manufacturing including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works collaboratively with senior site and company leadership to ensure production, cost, and compliance objectives are achieved.
Responsibilities
Manufacturing and Supply
- Responsible for all cGMP manufacturing at a site.
- Responsible for operational activities including packaging, buffer and media preparation, fermentation & purification operations, and oversight of warehouse management.
- Supports execution of the site production plan - accessible and ready to engage directly when critical issues arise or when leadership presence is needed to support the team. Routinely oversees production activities inside the manufacturing facility.
- Leads the development and execution of the site production plan in support of commercial and clinical manufacturing commitments provided via the master production plan; achieves a high degree of schedule adherence and proactively communicates schedule changes to site leadership team and key stakeholders.
Organizational Performance & Development
- Provides clear direction and motivation to direct reports and other staff to achieve short- and long-term objectives.
- Develops and maintains strong working relationships within the site and external to the site; leads efforts to work collaboratively across the entire corporation to meet objectives.
- Develops and coaches direct reports and other staff to maximize personal growth opportunities; develops programs for employee engagement, development and training.
- Promotes and drives a right first time culture focused on mistake proofing and continuous improvement; leads organizational change initiatives focused on continuous improvement.
Qualifications
Education & Experience
- Minimum BS in Chemical Engineering, Biology or life science, advanced degree (MS) preferred, or equivalent relevant experience.
- 10-12+ years’ relevant experience in the pharmaceutical industry, with at least 5 years’ experience in a leadership role; commercial biologics manufacturing experience preferred.
- Proven ability to lead teams, drive change, and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory inspections.
Knowledge
- Strong knowledge of biologics manufacturing technologies & processes including upstream and downstream operations, technology transfer, scale-up, testing, and validation requirements.
- Knowledge of cGMP, FDA, DEA and related international regulations.
- Quality systems, batch documentation, and inspection readiness
- Technology transfer, including CMC documentation and scale-up procedures
- Supply chain operations, vendor qualification, and logistics coordination
- Industry trends in automation, digital manufacturing, and predictive analytics
- Employee engagement strategies and training program development
- ERP and manufacturing systems such as SAP or Oracle is plus
- Financial/cost accounting experience managing multiple cost centers and budgets.
Skills & Abilities
- Ability to align operational activities with strategic goals
- Proficient in planning and managing production schedules
- Strong troubleshooting technical issues and optimizing manufacturing processes
- Experienced in leading cross-functional initiatives and technology transfers
- Capable of developing budgets and implementing cost control strategies
- Adept at coaching and developing staff to enhance performance and engagement
- Drives change initiatives and fosters a culture of continuous improvement
- Collaborates effectively across departments and teams
- Team player with a strong customer orientation and ability to manage complex operations in a dynamic, team based environment.
- Analytical, data-driven decision maker with the ability to quickly get to the fundamental root cause of problems and issues in order to implement solutions and/or facilitate rapid resolution.
- Strong negotiation, written communication, and public presentation skills.
Physical Requirements
- Primarily operates in a professional office setting with regular visits to manufacturing areas, which include cleanrooms and controlled environments. Ability to wear a sterile gown and don shoe covers as needed
Technical Support
- Provides technical expertise and manufacturing support for trouble shooting of manufacturing processes, investigations, process improvements, and supplier and material qualification.
- May partner with R&D to support clinical supply requirements and to develop and implement new manufacturing processes to support pipeline products.
- Identifies and implements continuous improvement projects to improve cost and compliance within manufacturing operations.
Quality & Compliance
- Provides leadership and supports the organization’s quality and compliance objectives, ensuring the facilities are in a constant state of inspection readiness and compliant with regulatory agency requirements.
- Ensures staff initiates and maintains appropriate training required to perform required job responsibilities and manufacturing activities are performed according to cGMP standards and all applicable Regulatory requirements.
- Creates and maintains batch documentation, operational procedures, and records to support site operations.
- Participates in Regulatory inspections/audits as the manufacturing site lead.
- Conducts manufacturing operations in accordance with applicable EH&S regulations ensuring team members operate with a focus safety and compliance.
Financial
- Recommends annual expense and capital budgets for approval.
- Manages annual spending and production costs according to approved plans.
- Identifies and implements cost improvement opportunities to drive manufacturing efficiency.
