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Team Lead API Manufacturing-2nd Shift

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
May 19, 2022
Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will support multiple buildings within the API Fermentation Isolation area. You will coordinate the manufacture of key API (Active Pharmaceutical Ingredients) Intermediate processes and/or biotechnology products in compliance with good manufacturing practice (GMP) guidelines, and federal, state, and local Environmental and Safety Regulations.

You will provide appropriate technical support to process teams to sustain and improve the processes. You will ensure flawless execution throughout each assigned campaign, focusing on the fundamentals of safety, quality, supply and cost. Cost Improvement Projects (CIP) development will also be a key part of your role.

Your responsibility within the unit will include assuring that the unit manufactures the forecasted volume with the appropriate resources. You will review batch records, support release of production lots, and will assist in the execution of Pre/Post Campaign Reviews.

As a Team leader, you will be involved in leading work teams within a division. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities.

You will be relied on to solve complex problems within your area of expertise. You will also champion various aspects of our IMEx journey including leading/co-leading efforts related to standard work and, in conjunction with other shifts.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Manage multiple projects and ongoing work activities within a team.

  • Monitor and manage the efforts of subordinate colleagues to achieve delivery of short-term goals.

  • Schedule staffing to meet customer needs and schedule attainment, within budget guidelines.

  • Facilitate regulatory and customer audit tours and complete operational quality, environmental, and safety incident investigations.

  • Responsible for providing audit responses and implementing corrective actions in accordance with due dates.

  • Sponsors unit meetings and helps champion unit initiatives that impact Quality, Environment, Health & Safety Supply and cost.

  • Represent the organization in providing solutions to difficult issues associated with specific problems.

  • Have responsibility for the co-ordination, planning and execution the production schedule and all process changeovers in your assigned multi-product manufacturing facility with the highest safety and quality standards.

  • Operate within established HR policies and guidelines.

  • Engage in colleague development, including timely performance feedback and appraisal.

  • Use functional knowledge and Pfizer-specific principles, theories, concepts and practices to improve operations.

  • Administers policies & procedures that affect individual subordinate colleagues in assigned units only.

QualificationsMust-Have

Education and prior manufacturing experience required for this role. Prior experience to include providing Qualifying Military experience may also be considered in lieu of industrial experience. Specifics as follows:

  • Education and prior pharmaceutical and/or manufacturing experience required for this role. Prior experience includes strong knowledge, support and capability related to manufacturing operations, methods and practices. Qualifying military experience may also be considered in lieu of industrial experience. Specifics as follows:

    • Bachelor's degree in Engineering, Business or Science with a minimum of 3+ years of experience and 1+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment

    • Associates Degree with a minimum of 5+ years of experience and 3+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.

    • High School Diploma with a minimum 7+ years of experience and 5+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.

  • Demonstrated ability to manage and plan budgets

  • Demonstrated ability to deliver improvements to site performance with the use of Lean and Six Sigma tools

  • Strong technical, analytical and problem solving skills

  • Demonstrated problem solving and business decision making

  • Contact with outside organizations and customers. Strong people management experience

  • Excellent people and communication skills to provide guidance and support to their teams which enables their teams to grow and develop

  • Computer Skills, such as Microsoft Applications, willingness to learn and utilize System Application and Products Quality Tracking Systems

Nice To Have

  • Experiencing a GMP and PSM covered environment

PHYSICAL/MENTAL REQUIREMENTS

Physical Demands:

  • Frequent time in both manufacturing and office environments.

  • The manufacturing environment includes equipment with moving parts.

  • Must be able to perform gowning requirements for entry in the manufacturing areas.

  • Requires lifting, sitting, standing, walking, stair climbing and roof access.

  • Must be available to support 24/7 – 365 operation.

Work Environment:

  • Office environment, with frequent time in the manufacturing areas.

  • Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.

  • Use of hearing and eye protection is required.

  • Must be available to support 24/7 – 365 operation.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Role supports a 24-hour production environment.

  • This position is primarily 2nd shift (3pm-11pm). However, to accommodate unit and site meeting schedules, some time spent on 1st and 3rd shift is expected.

  • Weekend and holiday coverage may be required.

  • Relocation support available.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

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