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Senior Tech Transfer Engineer - Clinical Manufacturing for Advanced Therapies

Employer
Pfizer
Location
Durham, North Carolina
Salary
Competitive
Closing date
Dec 13, 2022

View more

Discipline
Physical Sciences, Engineering, Other, Manufacturing/QA/QC
Position Type
Full Time
Organization Type
Pharma
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Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

Situated within Pfizer's Research and Development (R&D) organization, the Durham Clinical Manufacturing Facility (DCMF) is helping to lead the health care industry in the rapidly expanding field of AAV gene therapies and RNA manufacturing. 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 It

The Senior Tech Transfer Engineer works to lead the process transfer from development labs into a pilot scale cGMP manufacturing facility, for the production of early clinical stage cGMP material. Working closely with the Process Development, Manufacturing, and Portfolio Management 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 technology transfer lead for new investigational products for First in Human use. Includes complex modalities such as AAV gene therapies and RNA vaccines
  • Leads multiple on-going projects and manufacturing campaigns, up to 4+ per year
  • Collaborates with other Pfizer sites to develop, align, and implement best practices as it relates to process transfer activities
  • Partners with Process Development, Manufacturing, and Portfolio Management groups to ensure implementation of drug substance and drug product manufacturing processes into cGMP clinical manufacturing.
  • Utilizes project management principles to assemble and lead project teams, develops detailed project schedules, identifies and mitigates project risks
  • Drive system level changes and improvements to process transfer activities, across multiple business lines
  • Leads creation of process specific documentation including production batch records
  • Serves as a mentor junior staff members


Qualifications

Must-Have

  • Degree in Engineering or Science discipline: B.S./B.A. with 8+ years direct experience in biopharmaceutical cGMP manufacturing and/or Process Development
  • Technical understanding of drug substance biotechnology manufacturing process
  • Project management experience of complex technical projects, including demonstrated experience in influencing and leading cross functional teams


Nice-to-Have

  • Prior work experience in cGMP clinical manufacturing, AAV manufacturing or process development, or RNA manufacturing or process development.
  • Master's or other advanced degree
  • Project Management Processional (PMP) certificate


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
  • Infrequent off-hours work to support manufacturing

Work Location Assignment: Flexible

Relocation assistance may be available based on business needs and/or eligibility.

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.

Research and Development

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