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Manager/TL Aseptic Manufacturing (3rd Shift)


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Job Details


Successful candidate will lead a team of operations colleague in the production of aseptic pharmaceutical products. Production responsibilities include:

+ Excipient dispensing

+ Sterile micronizing

+ Sterile formulation and gel compounding

+ Aseptic syringe filling

+ Sterile parts preparation (cleaning, assembly and sterilization)

+ Aseptic facility sanitation


+ Responsible for effective leadership of assigned operations team which includes ensuring: the safety of team members and the operation, cGMP's are followed, production SOP's are upheld, and production schedules are met. The Manager/TL will work with the team to define metrics and strategy to achieve results. Manager/TL will act as coach and mentor to transform team into a cohesive, harmonized team. Responsible for counseling colleagues to assure proper development for their success, supporting all colleagues to ensure they each reach their full potential, and to provide corrective action when necessary. Provide an environment that encourages creativity, innovative ideas, and engagement. Manager/TL is also responsible to ensure timely performance feedback and appraisals for all team members.

+ Position is responsible for the complete aseptic manufacturing of all products within the Rochester site. This position requires in depth knowledge of aseptic processing and compliant aseptic practices to ensure products are made in a safe manner. Strong teamwork and technical skills required. Will troubleshoot and solve production process problems with processes or equipment already in operation. Requires understanding of compliance, pharmaceutical and cGMP requirements. Due to the inherent risks associated with aseptic manufacturing, the selected candidate must demonstrate a clear competency analyzing risks with respect to patient safety.

+ Responsible for leading team in identifying and implementing efficiency, safety, quality and cost improvements on equipment and processes. Possesses the ability to critically analyze manufacturing processes for reproducibility, ruggedness, and root cause failure investigations of day to day operations. Requires developing strategies and systems to improve process performance. Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting customer expectations and requirements.

+ Candidate will lead Operational Excellence initiatives (i.e. Kanban, M1 investigations, GB certification, etc.), develop operational excellence skills of colleagues, and drive a culture of continuous improvement with their team.

+ Understanding and application of industry, functional and Pfizer-specific principles, theories, concepts and practices. General knowledge of other related disciplines. Knowledge of basic leadership principles. Focus is on leading/overseeing defined processes and production colleagues, which may require deep, detailed knowledge.

+ Provide solutions to a wide range of difficult/complex problems which require the regular use of ingenuity, innovation, and creativity. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships. Solutions are imaginative, practical, thorough, and in line with organization objectives. Able to adapt and respond positively to situations and people in order to meet changing work unit priorities. Operates within established HR policies and basic colleague relations guidelines.


+ **Education:** A Bachelor's degree with minimum 9 years related experience or a Master's degree with a minimum of 5 years related experience.

+ **Experience:** Previous supervisory or related experience preferred. The ideal candidate will have aseptic manufacturing experience and a strong personal motivation and aptitude for coaching, leading and managing individuals and teams. An aptitude for understanding process technology and equipment, aseptic processing, proven leadership ability, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with all levels of the organization. Candidate must possess flexibility to respond to constantly changing conditions and priorities. Previous experience in process engineering or microbiology desired.


+ Expected to spend majority of time on the shop floor, and be trained in the appropriate gowning. This position requires the candidate to work weekend/alternative shifts supporting the production schedule. This is a Penicillin site; the candidate must NOT be allergic to Penicillin.


+ This is a 3rd shift position with core hours from 11:00pm until 7:30am. Job will require weekend/alternative shift work supporting the production schedule. Limited travel may be required.

**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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees

**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.

**Last Date to Apply for Job: 3/1/2018**

+ Additional Location Information: Rochester, MI

+ Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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