Manager, Gene Therapy, Upstream

Sanford, North Carolina, United States
Sep 12, 2020
Required Education
Bachelors Degree
Position Type
Full time
Role Summary

The Manager, Gene Therapy 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. Functional areas to be supervised include: solution preparation and upstream processing.

The Manager, Gene Therapy 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 primary goal of the Manager, Gene Therapy is to optimize resources to maximize production and ensure quality and safety standards.

Role Responsibilities
  • Ensure a safe work environment. Ability to identify, evaluate, and correct potential hazards in the workplace is essential.
  • Coordinate, schedule, and participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
  • Ensure that product quality is maintained through all phases of process validation and commercial production, including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics, and integrated utilities to identify and 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 exempt and hourly direct reports. Motivate personnel by setting high standards and encouraging teamwork. Clear, unambiguous communication is critical.
  • Primary contact for all personnel issues occurring within the department. Responsible for development plans and personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, and emergency situations (including injured employees, facility issues & inclement weather).
  • Review completed batch records. Develop training material, update curricula, close training gaps, and support the training of new supervisors.
  • Advise management of non-conformance issues and 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.

Basic Qualifications
  • BS degree with 5-8 years of FDA/GMP manufacturing experience required. MS degree with 3-5 years of FDA/GMP manufacturing experience may also be considered.
  • Minimum of 2 years supervisory or management experience is required.
  • Must have hands-on experience with adherent and/or suspension cells from flasks to large-scale bioreactors.
  • Must have experience in upstream process (cell culture) and equipment troubleshooting.

Preferred Qualifications
  • BS and/or MS in science or engineering field preferred.
  • Three or more years working knowledge of gene therapy, vaccine or biotechnology product manufacturing in a cGMP environment. Including a working knowledge of small to large scale cell culture in single use bioreactors (Flasks, Waves, SUB), perfusion, transfection, media preparation in stainless steel bioreactor, CIP, SIP, and Depth filtration processes.

Other Job Details
  • Last Date to Apply for Job: 9/15/2020
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE

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.