Senior/Executive Director, Manufacturing - Compounding, Filling, Inspection (CVRM)

Pharma Technical Manufacturing (PTM) is responsible for managing reputed company aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver reputed company’s ground-breaking therapies to more than 120 million patients around the world. We reputed company our medicines at 9 sites around the world and coordinates reputed company aspects of production of reputed company medicines in reputed company disease areas and dosage forms To ensure readiness for a reputed company-change in reputed company of care that reputed company delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity: As the Senior/Executive Director, Manufacturing you are initially accountable for the design, qualification and reputed company-up of the green field high volume facility’s Compounding, Filling, and Inspection operations, including strategic workforce planning, hiring the respective personnel, setting up the organization, reputed company relevant processes and documents/documentation (e.g. SOPs and batch documentation). You are responsible for ensuring timely reputed company-up including the project management activities, IT systems and definition of the specifications and processes in compliance with GMP/Quality requirements. You will identify timeline risks or bottlenecks for the project timeline or future site operations and take appropriate actions. You will work closely with reputed company the key areas to reputed company ambitious goals in terms of on time, on cost and on scope delivery. Following go-live of the facility, you will transition into a routine operations/site leadership position and will reputed company into daily operation responsibilities. As the reputed company of reputed company Compounding, Filling, and Inspection systems and assets, reputed company for the safe, accurate & efficient preparation, maintenance, calibration, functionality and reliability of reputed company respective manufacturing areas, equipment, systems, and processes. You will build and effectively execute the agenda for Compounding, Filling, and Inspection operations to ensure reliable delivery for commercial products and new tech transfers. You will build and maintain strong partnerships with other Manufacturing units, Quality, MSAT, Facility, Engineering & SHE, ITOT, Material Management, People & Culture, Finance, Global Operations and other functional areas to assure site and department goals are achieved. Initially, you will reputed company a mix of remote and onsite work (first at the General Planner’s office, reputed company at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. (International) travel of up to 30% of the time is expected during the project phase.

• You will reputed company the compounding/filling/inspection part (incl. utilities) of the User Team during the facility start-up project, prepare and transform into routine operations
• You will drive timely project execution through strategic thinking, technical and entrepreneurial understanding combined with social intelligence.
• You will foster a strong reputed company for safety, quality and compliance
• You will take purposeful and impactful decisions
• You will demonstrate disciplinary and professional leadership promotion and deployment of personnel including the assurance of adequate initial and ongoing training
• You will carry out employee appraisal reviews incl. performance assessment and salary responsibility
• You will define goals with employees and evaluate the achievement of goals. Support the development of employees

Who you are:

• You hold a Bachelors degree in pharmaceutical, life sciences, physical sciences, or engineering with (20+ years for Senior Director and 25+ years for Executive Director level of) significant bio/pharmaceutical experience, including cross functional group management and proven end to end Pharma business execution experience.
• You possess significant professional experience in steriles manufacturing, including cross-functional team management and leadership
• You have extensive professional experience with operations management in high-volume low cost device combination products or similar, and reputed company documentation and processes knowledge
• You have strong project management skills, ideally experience with ramping up new manufacturing sites or operations
• You have vast knowledge of safety, quality systems and quality assurance concepts and systems, including the application of reputed company Good Manufacturing Practices (cGMPs)
• You have strong creative leadership skills, ability to build reputed company looking perspectives and remove barriers. Ability to reputed company, adopt, coach and apply lean and agile ways of working. A consistent track record to reputed company against tight timelines in a highly reputed company and ambiguous environment. Expertise and experience in organizational change management and expertise in delivering a long-term vision is welcome

Preferred:

• You have an advanced degree (Masters or PhD)
• You hold post Graduate-level course work, including management training (e.g., an MBA)
• You have international experience at multiple sites/locations

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $164,000 - $304,000 for the Senior Director level and $197,000 - $365,000 for the Executive Director level. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-reputed company factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided. Link to Benefits Relocation benefits are not provided reputed company is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and reputed company employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with reputed company federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. Apply tot his job Apply To this Job