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Technology Transfer Lead - Clinical Manufacturing

Employer
Pfizer
Location
Chapel Hill, North Carolina
Salary
Competitive
Closing date
Mar 6, 2021

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Pfizer's Chapel Hill site is helping Pfizer to lead the health care industry in the rapidly expanding field of gene therapy. We are working to bring exciting new treatments into the clinic with the promise of changing patients' lives.

Pfizer Chapel Hill partners with our process development groups to manufacture early clinical stage cGMP material, producing both drug substance and drug product material. The work environment gains team members exposure to numerous aspects of cGMP manufacturing while working at the clinical manufacturing scale. The small size of the Chapel Hill site necessitates a team focused culture, allowing for empowerment and ownership at all levels.

Gene therapy is a significant growth area within Pfizer's portfolio. Pfizer is committed to the success of Chapel Hill and has recently announced the purchase of a new clinical manufacturing facility. The new facility will more than double our current capacity as we continue to deliver new gene therapy treatments.

The Chapel Hill manufacturing facility is located on the edge of RTP right off Interstate 40. The new facility is located near the Interstate 40 and 540 intersection and is scheduled to open in 2021.

The Technology Transfer Specialist position provides project management and oversite of clinical manufacturing campaigns. Working closely with the Process Development group, this role will plan future campaigns, ensuring facility readiness, and providing updates to the global Pfizer network.

ROLE RESPONSIBILITIES
  • Lead tech transfer activities for new investigational products, from Process Development into cGMP clinical manufacturing.
  • Owns project management activities such as developing and tracking project timelines, and overseeing facility readiness (e.g. equipment on-boarding, GMP documentation creation, materials oversite, etc.)
  • Single point of contact for cGMP manufacturing, for global Pfizer network. Tracks campaign progression and takes appropriate actions to identify, communicate, and mitigate project risks.
  • Leads, participates, and coordinates project teams to ensure campaign updates are communicated timely and succinctly. Provides and receives input on campaign progress and planning. Ensures delivery of clinical material to meet Pfizer's portfolio strategy.
  • Lead or assist in process related investigations during manufacturing campaign, as needed.
  • Perform campaign closeout activities such as author campaign summary report upon campaign completion and provide support for regulatory filings.
  • Lead and support the creation of manufacturing batch records and various cGMP documentation.
  • Support and coordinates training of operations colleagues for new processes, as needed


Qualifications

Must-Have
  • Degree in Engineering or Science discipline.
  • B.S./B.A. with 5 years or M.S. with 2 years of direct experience in biopharmaceutical GMP manufacturing.
  • 2+ years of Project Management and/or Technology Transfer related experience.


PREFERRED QUALIFICATIONS
  • Prior experience in a cGMP clinical manufacturing.
  • PMP certified or in progress.
  • Advanced scientific degree (M.S.).
  • Demonstrated excellence in project management, including timeline development, risk identifications/mitigation, and stakeholder management.
  • Knowledge of common biotechnology processes including mammalian cell culture, associated purification steps, and drug product manufacturing.
  • Demonstrated capability to work as a team member in a matrix team.
  • Excellent time management and multi-tasking skills.
  • Adaptability to changing work environment and priorities.
  • Excellent oral and written communication skills.
  • Ability to work under minimal supervision.


PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to gown into cleanroom environment when needed.
  • Must be able to perform complex data analysis.


Other Job Details:
  • Last Date to Apply for Job: March 11, 2021
  • Eligible for Employee Referral Bonus: YES


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.

Research and Development

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