25 days old

Group Leader, Purification, Gene Therapy

Pfizer
Morrisville, NC 27560
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**ROLE SUMMARY**

A Purification Group Leader position is available within the Gene Therapy Process Development group in Bioprocess R&D. The successful applicant will be responsible for developing innovative, robust, efficient, and scalable purification processes and technologies required for the advancement of Pfizer's growing gene therapy program. They will be expected to provide strong technical, strategic and organizational leadership so as to ensure efficient and timely execution of group deliverables. The position will focus on process design, unit operation scale-up and scale-down and apply rigorous scientific and engineering principles and approaches to all aspects of purification process development.



The Group Leader will work closely with other leaders in the group to develop new technologies and deliver the project portfolio. This position supports project management and other Bioprocess R&D functions to facilitate the timely delivery of processes and pre-clinical/clinical supplies of AAV vectors; supports transfers to pilot facilities to meet supply objectives for clinical materials, ensures that scalable processes are developed that are ready for process validation and commercialization.



The Group Leader (Senior Principal Scientist) role is responsible for planning and developing a staff of 4-8 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. This position will be expected to prepare internally reviewed technical reports, contribute to regulatory filings, make oral presentations to scientists and management, and publish externally. The Group Leader will be responsible for identifying and implementing operational efficiency improvements. The successful candidate must be capable of implementing change to business infrastructure to ensure pipeline, legacy and technology success.



**ROLE RESPONSIBILITIES**



+ Demonstrated supervision / leadership of high caliber engineers and scientists; ability to mentor junior staff and peers

+ Experience in supporting the scale-up and technology transfer to pilot / commercial scale.

+ Experience developing commercially relevant process for products derived from mammalian and microbial processes.

+ Experience with chromatographic and membrane based separations.

+ Experience with all aspects of membrane filtration, viral clearance and filtration.

+ Extensive knowledge of drug development (with a particular strength in the area of purification process technologies).

+ Demonstrated experience with managing multiple development projects in parallel, including key participation on multi-disciplinary project teams.

+ Good knowledge of GLP/GMP and Biotechnology CMC regulatory requirements.

+ Familiarity with process development utilizing quality risk management and quality by design concepts.

+ Excellent oral and written communication skills.



**BASIC QUALIFICATIONS**



+ Ph.D. degree in Chemical/Biochemical Engineering, Biochemistry, or equivalent with 8+ years of experience or Masters degree with 15+ years of experience



**PREFERRED QUALIFICATIONS**



+ Over 8-15 years relevant work experience in Chemical/Biochemical Engineering, Biochemistry, or equivalent, including process development, process scale-up, technology transfer, and support for process validation and commercial production, within the Biopharmaceutical industry.

+ The candidate should have demonstrated technical expertise in developing chromatographic and membrane based separation processes.

+ Experience contributing to regulatory submissions including IND, BLA, and MAA is required.

+ Demonstrated leadership success in both project and people management. This position requires highly motivated individuals with the ability to work closely with other members of the laboratory and the department in a matrix team environment to also drive novel innovative technology strategies.

+ Demonstrated ability to drive for results and lead innovation and change.

+ Collaborative, team oriented leadership and management style essential. Applicants should be bright, organized, self-motivated, and capable of working independently, and in a collaborative environment.

+ The successful candidate will possess strong oral and written communication skills. Strong analytical and computer skills are required.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Ability to perform mathematical calculations and ability to perform complex data analysis



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Travel to other Pfizer sites (Chesterfield, MO and others) and to support process technology transfers to contract manufacturing organizations in US and rest of the world as appropriate.



**Other Job Details:**



+ **Last Date to Apply for Job: December 14, 2020**

+ Eligible for Relocation Package: YES

+ Eligible for Employee Referral Bonus: YES



**\#LI-PFE**



**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
Posted: 2020-11-09 Expires: 2020-12-10
Sponsored by:
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Group Leader, Purification, Gene Therapy

Pfizer
Morrisville, NC 27560

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