Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
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.
Job Description
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.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
