Position Summary
This position is responsible for overseeing the daily execution of sterile drug product manufacturing, ensuring timely production, and supporting plant maintenance and reliability initiatives. The role also contributes to cross-functional project execution, including the implementation of new product launches aligned with the organization's strategic growth in the radiopharmaceutical industry.
Key Responsibilities
- Provide day-to-day leadership and direction to the manufacturing team
- Ensure safe, compliant, and efficient execution of aseptic manufacturing processes
- Serve as a subject matter expert on aseptic technique, regulatory compliance, and sterile production
- Partner closely with Quality, Engineering, Maintenance, and other cross-functional departments
- Support site readiness for internal and external audits and regulatory inspections (FDA, EU, HC, ISO, etc.)
- Ensure production schedules are met to support commercial demand
- Support the implementation of new product initiatives and capital improvement projects
- Maintain adherence to all cGMP, safety, and radiation safety requirements
- Lead and develop direct reports; foster a culture of accountability and continuous improvement
- Utilize lean manufacturing and/or Six Sigma tools to drive operational efficiency
Qualifications
- Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field
- Minimum of 7 years' experience in pharmaceutical manufacturing, including 5 years in leadership roles
- Strong expertise in sterile/aseptic manufacturing of parenteral products
- In-depth understanding of regulatory standards and validation requirements in highly regulated industries
- Demonstrated success in leading multi-disciplinary teams
- Effective project management, prioritization, and communication skills
- Ability to lead in dynamic, high-pressure environments
- Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, SharePoint), MS Project, and Visio
- Experience in radiation safety or working with radioactive materials preferred
- Lean/Six Sigma certification is a plus
- Willingness to travel up to 5% of the time