Technology Transfer Lead - Clinical Manufacturing

Employer
Pfizer
Location
Durham, North Carolina
Salary
Competitive
Closing date
Jul 5, 2022

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Sector
Pharmaceutical, Supply Chain, Quality Assurance
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

Pfizer's Durham Clinical Manufacturing Facility (DCMF) is helping Pfizer to lead the health care industry in the rapidly expanding field of AAV gene therapy and biotechnology. We are working to bring new treatments into the clinic with the promise of changing patients' lives. The newly constructed DCMF partners with our Process Development teams to manufacture early clinical stage (Ph1/2) cGMP material, producing both drug substance and drug product. The facility is located near the Interstate 40 and 540 intersection

How You Will Achieve

The Technology Transfer Lead works to support the process transfer from development labs into a cGMP manufacturing facility, for the production of early clinical stage cGMP material. Working closely with the Process Development and Manufacturing groups, this role will plan future campaigns while ensuring facility and manufacturing readiness. The role may cover multiple modalities include AAV viral vectors, RNA vaccines, and future biotechnologies.
  • Serves as tech transfer lead for new investigational products for First in Human use. Includes complex modalities such as AAV gene therapies and RNA vaccines
  • Supports multiple on-going projects and manufacturing campaigns, up to 4+ per year
  • Partners with Process Development and Manufacturing groups to ensure implementation of drug substance and drug product manufacturing processes into cGMP clinical manufacturing.
  • Assembles and leads project teams to complete manufacturing readiness activities (material forecasting, equipment on-boarding, automation support, etc.)
  • Leads creation of process specific documentation including production batch records
  • Develops system level process improvements to improve ways of working within technology transfer across business lines


Qualifications

Must-Have

  • Degree in Engineering or Science discipline: B.S./B.A. with 7+ years or M.S. with 5+ years of direct experience in biopharmaceutical GMP manufacturing.
  • 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


Nice-to-Have

  • Prior experience in a cGMP clinical manufacturing and/or AAV manufacturing
  • In depth technical knowledge of biotechnology processes including mammalian cell culture, associated purification steps, and drug product manufacturing.
  • Advanced scientific or engineering degree (M.S.)
  • Project Management and/or Technology Transfer related experience
  • Demonstrated excellence in project management, including timeline development, risk identifications/mitigation, and stakeholder management


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


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Ability to work in a clean room environment
  • Minimal travel for training/transfer meetings may be required


Other Job Details:
  • Work Location Assignment: Flexible. Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.


#LI-PFE

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.

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