Job Description

ROLE SUMMARY

The Portfolio Project Lead (PPL) is a newly created position in the BTx Drug Product Clinical Manufacturing Technical Services Group. The PPL is responsible for overseeing the technology transfer for a portfolio of projects in a therapeutic area from early phase through commercial launch.

The Technical Services Group (TSG) is responsible for managing Phase I to III sterile drug product clinical manufacturing at multiple Contract Manufacturing Organizations (CMOs) and commercial Pfizer Global Supply (PGS) sites in the US and Europe. The Portfolio Project Lead (PPL) will provide oversight and direction to projects and Technical Services Leads (TSLs) responsible for multiple projects to ensure consistent and timely technology transfer and manufacture of clinical drug products.

ROLE RESPONSIBILTIES

* Oversees technology transfer from Phase I through commercialization for the portfolio area of responsibility.
* Works with stakeholders in the network to define manufacturing site needs and guides TSLs to ensure successful transfer of manufacturing processes.
* Contributes to development of business and technical practices in area of responsibility.
* Consults with other PPLs to ensure consistency in manufacturing as well as approach to technology transfer and regulatory filings.
* Works with TSG operations to determine and allocate required TSL resources and project assignments.
* Advises TSLs as necessary and provides guidance to projects in the portfolio area of responsibility.
* Works with TSLs to ensure proper levels of experience in multiple focus areas and unit operations.
* Reviews regulatory filings from INDs through BLAs to ensure technical clarity, consistency and appropriate level of detail.
* Participates in audit support activities and advises manufacturing sites in the network.
* Manages relationships with stakeholders and TSG partners and facilitates resolution of issues when needed.
* Conducts regular technical review meetings with TSLs and senior management to discuss development and manufacturing activities.
* Develops understanding of various manufacturing sites and their capabilities and works with Operations Manager to document and update these capabilities as needed.
* May act as the TSL for a limited number of highly complex projects.

QUALIFICATIONS

* Bachelors degree in a scientific or engineering discipline with a minimum of 7 years of experience.
* Technology transfer experience in sterile drug product manufacturing is required.
* Experience with development process from candidate selection to license application.
* Experience with projects and portfolio management.
* Experience with Gene Therapy modalities is highly desired.
* Excellent communication skills and ability to work in a matrix organization.

Non- Standard Work Schedule, Travel or Environmental Requirements

* About 10% Domestic and international travel may be required.

Other Job Details:

* Last Date to Apply for Job: April 5, 2021
* Eligible for Employee Referral Bonus: YES
* Additional locations: St Louis (Chesterfield), MO

Sunshine Act

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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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