Director, Clinical Manufacturing Technical Services Group, Phrd

Pfizer Andover , MA 01810

Posted 1 week ago

ROLE SUMMARY

The PhRD Clinical Manufacturing Technical Services Group (TSG) Director will lead a team with responsibility for management of sterile clinical drug product manufacturing and technology transfer for internal Pfizer and external Contract Manufacturing Organizations (CMOs). The position is located in Andover MA and will directly interface with FPD (Formulation and Process Development) group within Pharmaceutical Research and Development (PhRD), Quality Assurance (QA), Analytical, project teams Pfizer Global Supply (PGS) Manufacturing and Global Clinical Supplies (GCS). The TSG Director will establish strategy and objectives for multiple high complexity projects working in conjunction with PhRD and stakeholder leadership.

ROLE RESPONSIBILITIES

  • Lead a dynamic group to most effectively manage Phase I and II sterile vial and pre-filled syringe drug product clinical manufacturing at multiple Contract Manufacturing Organizations (CMOs) as well as Phase III and commercial launch sterile drug product manufacturing at Pfizer commercial sites in the US and Europe.

  • Establish and implement strategy to support manufacturing of evolving and complex portfolio.

  • Closely work with formulation and process development leadership to direct development of new drug product manufacturing processes for internal and external manufacturing sites.

  • Develops solutions to problems impeding the ability to transfer technology or support manufacturing and implements appropriate change.

  • Leads by example closely working with CMOs, QA, Analytical, Formulation and Supply Chain organizations to ensure timely manufacture and delivery of clinical supplies for parenteral drug products.

  • Lead manufacturing team discussions to ensure manufacturing readiness to meet clinical supply needs based on agreed schedules

  • Represent Tech Services group on site during engineering trials and clinical manufacturing of drug product supplies at CMOs and Pfizer PGS sites.

BASIC QUALIFICATIONS

  • Minimum BS required, degree in a scientific discipline, Life Science or Engineering is preferred.

  • Minimum of 15 years drug product experience in the biopharmaceutical industry

  • Must have knowledge of biologics manufacturing with a strong focus on drug product and aseptic processing

  • Must have knowledge of applicable Quality and Regulatory guidelines

  • Must have strong decision-making, leadership, interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management

  • Must work well in cross-functional teams

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.

Other Job Details

Eligible for Relocation Package: yes


Eligible for Employee Referral

Bonus:
yes

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.


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Director, Clinical Manufacturing Technical Services Group, Phrd

Pfizer