Sr Mgr/Team Lead, Drug Product Manufacturing Technology

Role Summary

This role is managing managers and leads the DPMT (Drug Product Manufacturing Technology) team supporting all technical aspects of finished dosage forms manufactured at the PGS-Kalamazoo plant which includes sterile injectables, non-sterile liquids/semi-solids, biologics, combination products, and medical devices. Key accountabilities include product/process technical stewardship, people leadership, technical problem solving, financial oversight, safety and compliance leadership, and customer service to assure the best service provided to site operational teams and global teams.

Responsibilities

• People and technical leadership support to DPMT and site Technical Services team.
• Product and process development, scale-up, technology transfer and validation support to all technologies on the site.
• Provide technical leadership in the investigations to determine root cause and implement appropriate corrective and preventive actions.
• Reviewing/providing feedback and technical/scientific support, i.e. remediation initiatives, plan reports, etc.
• Leadership and technical support for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures.
• Participate in start-up efforts of new equipment, software or processes in manufacturing. Serving as a scientific and technical representative for product/process related issues at the facility.
• Identify and lead process/product /device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs, and decrease process variability while maintaining regulatory compliance.
• Collaborates with technical staff to implement process technology initiatives.
• Technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects.
• Partner with Operations, Engineering, Quality, Safety, Supply Chain and other site and global colleagues to meet the production schedules, ensure technical excellence, commercial supply, uphold quality standards, driving towards zero defects.
• Actively support the successful completion of regulatory and customer audits, may serve as audit host during on-site regulatory inspections.
• Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development
• Drive continuous improvement through the use of Lean/Six Sigma tools.
• Serve as a main point of contact for DPMT team for internal (site), global Pfizer, and external customers.

Qualifications

• Required: Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience
• Required: Demonstrated scientific and people leadership skills. Experience leading teams of scientists with varying levels of experience and formal education (BS/MS and/or PhD).
• Required: Experience with cross-functional development of pharmaceutical/biotech products, including knowledge of key regulatory and quality/compliance expectations.
• Required: The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• Required: Demonstrated proficiency in challenging status quo, organizational and project management skills and must be able to balance multiple priorities. Empowering and enabling others to realize or exceed their full potential.
• Preferred: Experience in at least several of the following: Sterile injectable, non-sterile liquids product/process development and technology transfer; CMC, deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and regulatory filing/submission support.
• Preferred: Experience with biologics drug product and process development.
• Preferred: UpToDate with new technologies and applying these techniques and methods where appropriate
• Preferred: Work experience with pre-filled syringes and auto-injectors
• Preferred: Exposure to Process Analytical Technology
• Preferred: Expertise in lyophilization of products at large scale manufacturing facility, including development/improving of cycles and analyses of data output/trending.

Skills

• Technical leadership and people management
• Root-cause analysis and CAPA implementation
• Process development, scale-up, technology transfer, and validation
• Quality by Design (QbD) and Design of Experiments (DOE)
• Lean/Six Sigma toolset
• Cross-functional collaboration (Operations, Engineering, Quality, Safety, Supply Chain)

Education

• Degree requirements listed under Qualifications (bachelor’s, master’s, or PhD as specified)

Additional Requirements

• Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
• Minimal travel required (less than 10%).
• Work Location: On Premise