1+ months

Supervisor Gene Therapy Drug Product

Pfizer
Sanford, NC 27330
**ROLE SUMMARY**

- Ensure a safe work environment. Ability to identify, evaluate, and correct potential hazards in the workplace is essential.

- Coordinate, schedule & participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs.

- Must be flexible to work rotating shifts to support 24/7 operation. Ensure that product quality is maintained through all phases of commercial production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics & integrated utilities to identify & resolve quality risk to commercial manufacturing. General knowledge of scientific principles, production equipment & related procedures.

- Aid in investigations. Responsible for the adherence to established policies, procedures and practices. Participate in inspections and cGMP & Quality decisions effecting short term production

- Provide supervision to hourly direct reports. Motivate personnel by setting high standards, encourage teamwork. Clear, unambiguous communication is critical.

- Primary contact for all personnel issues occurring within the department. Responsible for development plans & personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, Emergency situations, including injured employees, facility issues & inclement weather.

- Review completed batch records. Develop training material, update curricula, close training gaps, support the training of new supervisors.

- Advise management of non-conformance issues & opportunities for continuous improvement

- Provide input on primary decisions on cGMP related documents developed or revised.

- Articulate challenges and solutions to technical and non-technical peers and to department management.

- Provide technical guidance and act as a departmental liaison with primary support groups.

- Short range planning includes scheduling daily and weekly operations and staff. Longer range planning concerns facilities shutdowns and preventive maintenance.



**ROLE RESPONSIBILITIES**

The Supervisor is accountable and responsible for leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service. Responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical responsibilities. Ensures that work performed by the assigned staff is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations.

Participates in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and/or cycle time. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are accurate and complete. Has a basic understanding of product cost structure, budgeting process and spending. The goal of the supervisor is to optimize resources to maximize production and ensure quality and safety standards.



**QUALIFICATIONS**

MINIMUM:

Supervisory or management experience is preferred.



DESIRABLE:

Three or more years working knowledge of biotechnology product manufacturing in a cGMP environment. Including a working knowledge of fermentation, purification, centrifugation, homogenization, Ultrafiltration and Diafiltration (UF/DF), aseptic techniques and drug product processes.



EDUCATIONAL BACKGROUND:

MINIMUM:

The following combinations of education and experience are considered acceptable:

BA/BS degree, preferably in a science or engineering field, with 3-5 years of FDA/GMP manufacturing experience or an MS degree, preferably in a science or engineering field w/a minimum of 1-2 years of FDA/GMP manufacturing experience.



o Last Date to Apply for Job: 5/10/2020

o Eligible for Employee Referral Bonus



**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

Categories

Posted: 2020-05-05 Expires: 2020-08-05

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Supervisor Gene Therapy Drug Product

Pfizer
Sanford, NC 27330

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