• Group Leader, Cell Culture Development, Gene Therapy Jobs in United States Of America

  • Pfizer Inc.
  • United States Of America, Usa

Job Description:

ROLE SUMMARY

The Gene Therapy Process Development group of Pfizers Bioprocess R&D organization in Morrisville, NC is seeking a highly motivated and energetic Principal Scientist to lead a team at the forefront of cell culture process development for to support Pfizers growing pipeline The successful applicant will be responsible for the development of early and late stage cell culture processes, tech transfer, process characterization, and authoring of associated regulatory submissions She/he will be expected to provide strong technical and strategic leadership and make significant contributions to cross-functional project teams to ensure efficient and timely execution of the teams deliverables

ROLE RESPONSIBILITIES

Responsible for successful development, characterization and tech transfer of state-of-the-art 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
The Principal Scientist (group leader) role is responsible for planning and developing a staff of 2-5 scientists and engineers, identifying growth opportunities and mentoring so that all staff can realize their full potentials, as well as dealing with performance issues appropriately Performance of all duties associated with the operation of effective research laboratories is expected, including mentorship of laboratory scientists
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
Demonstrates positive leadership qualities, mentors junior scientists, and fosters a collaborative team environment; models and engenders desired values and behaviors, including quality, integrity, respect, and personal accountability

BASIC QUALIFICATIONS

PhD degree with 3-8 years of experience, Masters degree with 6-11 years of experience, or Bachelors degree with 8-13 years of experience in Chemical/Biochemical Engineering or Life Sciences related field, with relevant industry experience in purification process development
Experience with successful process development, tech transfer and process scale-up to GMP manufacturing is required
Experience with cell culture process development is required
Strong oral and written communication skills as well as analytical and computer proficiencies

PREFERRED QUALIFICATIONS

Experience managing and developing direct reports (or contract staff) is preferred
Demonstrated ability to drive for results and lead innovation and change
Applicants should be organized, self-motivated, and capable of working both independently and collaboratively; adept at working in a fast-paced team environment with shifting priorities
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 (<10 PERCENT )

OTHER INFORMATION

Last Day to Apply September 6, 2019
Additional Location Information Morrisville, NC
Eligible for Employee Referral Bonus Yes
Relocation Eligible 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 providers 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

#LI-PFE

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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