Associate Director, Manufacturing Operations

Mallinckrodt Pharmaceuticals•Horsham, PA

12d•Onsite

About The Position

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.

Requirements

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.
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.
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.
Ability to wear a sterile gown and don shoe covers as needed

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.
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.