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Principal Scientist, Gene Therapy Upstream Process Development

Employer
Pfizer
Location
North Carolina - Morrisville, North Carolina
Salary
Competitive
Closing date
Sep 30, 2022

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Discipline
Physical Sciences, Chemistry, Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Staff Scientist
Organization Type
All Industry, Pharma
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ROLE SUMMARY

The individual will join a team of scientists and engineers focused on developing and optimizing upstream processes for production of Gene Therapies for early-phase and late-phase clinical trials. The individual will be involved in developing robust, scalable, highly productive cell culture processes, and accurate technology transfer of the processes to pilot scale, clinical, and commercial production facilities for successful large-scale manufacturing in support of Pfizer's growing pipeline. The job function requires sound scientific judgment and innovation using advanced practices and procedures to achieve solutions. The individual will be employing systems biology approaches towards enhancing process understanding/knowledge for reducing process development timelines, and help addressing issues surrounding productivity and product quality attributes across a wide array of product modalities.

ROLE RESPONSIBILITIES

  • Responsible for successful development, characterization and tech transfer of state-of-the-art upstream manufacturing processes for AAV cell culture production. Technical leader who applies scientific and technical expertise and business acumen to establish strategies, drive safe and efficient lab work, and deliver robust, high-quality, and high-yield manufacturing processes. Develops creative and pragmatic solutions to technical and operational challenges.
  • Performance of all duties associated with the operation of effective research laboratories is expected, including mentorship of laboratory scientists. Demonstrates positive leadership qualities and fosters a collaborative team environment; models and engenders desired values and behaviors, including quality, integrity, respect, and personal accountability.
  • Contributes to regulatory submissions and query responses; presents data/ strategy to peers and management in appropriate internal and external venues (technical meetings, project team meetings, conferences); authors technical reports, patent applications, and publications in peer-reviewed journals, as appropriate.
  • Establishes and drives relevant and impactful innovation programs that are aligned with business drivers and regulatory paradigms to enhance upstream manufacturing technologies and work processes.


BASIC QUALIFICATIONS

  • PhD degree with4+ years of experience, Master's degree with 9+ years of experience, or Bachelor's degree with 12+ years of experience in Chemical/Biochemical Engineering or Life Sciences related field, with relevant industry experience in upstream process development.
  • Experience with successful cell culture process development, tech transfer and process scale-up to GMP manufacturing is required.
  • Skilled in effective communication and management of cross-line and cross-functional efforts related to upstream bioprocess development.
  • Demonstrated ability to drive for results and lead innovation and change.


PREFERRED QUALIFICATIONS

  • Experience employing systems biology approaches towards enhancing process understanding/knowledge for reducing process development timelines, and help addressing issues surrounding productivity and product quality attributes across a wide array of product modalities.
  • Organized, self-motivated, and capable of working both independently and collaboratively; adept at working in a fast-paced team environment with shifting priorities.
  • Experience mentoring laboratory scientists is preferred.
  • Expertise in at least one of the following areas is preferred: mammalian cell metabolism, media development, advanced bioreactor controls, and PAT technologies.
  • Proficient in statistical experimental design and analysis of complex multi-variate processes


PHYSICAL/MENTAL REQUIREMENTS
  • Ability to perform mathematical calculations and ability to perform complex data analysis


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Occasional travel required for company meetings and technology transfer activities to manufacturing facilities (


Other Job Details
Relocation support available
Work Location Assignment:On Premise

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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