Manager/TL, API Manufacturing

Pfizer • Kalamazoo, MI

6d • Onsite

About The Position

This position will be supporting B66 - day shift. The successful candidate will supervise colleagues and temporary contract workers who are engaged and support in the production of APIs for pharmaceutical or biotechnology products in compliance with good manufacturing practice (GMP) guidelines, and federal, state, and local Environmental and Safety Regulations. This TL may facilitate (in conjunction with other area TL’s and staff) regulatory and customer audit tours and will complete operational quality, environmental, and safety incident investigations utilizing Method 1 and Pfizer Human Performance (PHP) investigational techniques. Also responsible for providing audit responses and implementing corrective actions in accordance with due dates. They also may be expected to support Environmental operating systems and work closely with the site Environmental team to ensure continued compliance with all site and regulatory environmental compliance standards. Responsible for controlling unit operating expenses. Assures the unit manufactures the forecasted volume with the appropriate resources. Schedules staffing to meet customer needs and schedule attainment, within budget guidelines. Team Leader will review batch records, support release of production lots, and assist in the execution of Pre/Post Campaign Reviews. Also responsible to be actively engaged in colleague development, including timely performance feedback and appraisal and other aspects of the performance management process. The successful candidate will be a key member of the area Process Centric Team. Accountabilities include responsibility for key operations related initiatives including evaluation of production variances, data analysis, driving actions as a result of key performance metrics, investigation of safety and quality deviations, driving a continuous improvement mindset, driving an incident and injury free culture, coaching shop floor colleagues and junior level supervisors. In conjunction with other staff and shop floor colleagues, the TL will help resolve both daily and long-term manufacturing issues to support the shop floor. They may also support division wide programs where appropriate, such as operator training programs and local documentation storage.

Requirements

• Bachelor's degree with at least 4 years of experience; OR a Master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an Associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Effective written and oral communication skills.
• Proficiency in Microsoft Applications.
• Willingness to learn and utilize SAP, eQMS, QPSNT, Enablon, Cority, & DOC.
• Demonstrated ability to manage and plan budgets.
• Demonstrated problem-solving and business decision-making skills.
• Ability to provide mentoring and training of less experienced team leaders, including in the use of investigational tools such as Method 1 and PHP.
• Permanent work authorization in the United States.

Nice To Haves

• API manufacturing experience.
• People leader experience.

Responsibilities

• Supervise colleagues and temporary contract workers in the production of APIs.
• Ensure compliance with GMP guidelines, and federal, state, and local Environmental and Safety Regulations.
• Facilitate regulatory and customer audit tours.
• Complete operational quality, environmental, and safety incident investigations using Method 1 and Pfizer Human Performance (PHP) techniques.
• Provide audit responses and implement corrective actions.
• Support Environmental operating systems and ensure compliance with environmental standards.
• Control unit operating expenses and ensure forecasted volume is manufactured with appropriate resources.
• Schedule staffing to meet customer needs and schedule attainment within budget guidelines.
• Review batch records, support release of production lots, and assist in Pre/Post Campaign Reviews.
• Engage in colleague development, including performance feedback and appraisal.
• Act as a key member of the area Process Centric Team.
• Evaluate production variances, analyze data, and drive actions based on key performance metrics.
• Investigate safety and quality deviations.
• Drive a continuous improvement mindset and an incident and injury-free culture.
• Coach shop floor colleagues and junior level supervisors.
• Resolve daily and long-term manufacturing issues.
• Support division-wide programs such as operator training and local documentation storage.
• Lead and motivate others, generating commitment and a shared sense of purpose.
• Empower others to contribute their best.
• Lead the implementation and sustainment of lean management principles (IMEx, Six Sigma) on the shop floor.
• Represent the organization as a contact on projects.
• Lead teams of diverse make-up, including cross-functional departments and colleague levels.
• Interact with senior internal and/or external personnel.
• Conduct briefings and participate in technical meetings.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Manager