Director, Early Bio Process Development

ROLE SUMMARY

You will oversee all technical aspects and logistics required for Viral strain change activities within the Vaccine Research and Development - Early Bioprocess Development group. You will organize all activities and resources required to manufacture and release DNA template, RNA drug substance and LNP drug product to support strain changes for existing vaccines.

KEY RESPONSIBILITIES

• Effectively plan for, execute, and document a manufacturing campaign to deliver DNA template, RNA drug substance and LNP drug product to support viral vaccine strain changes.
• Provides oversight to scientists following already established SOPs and methods to manufacture and release material.
• Leads direct reports and non-reports, reviewing all manufacturing and release plans, batch records and release data. Works directly with analysts to actively trouble-shoot activities.
• Interface with the Viral Vaccines strain change lead and key Early Bioprocess development leads throughout the year to actively de-risk campaigns to deliver required material on-time and right first time.
• Communicate effectively to stakeholders regarding delays or material quality issues.
• Publish all required documents (CoAs, batch records, production reports, etc.) to support a manufacturing campaign.
• Leads the team to manage budget, laboratories, and stay in compliance.
• Satisfactorily complete all assigned trainings in compliance with departmental requirements and follow appropriate safety practices in the workplace

BASIC QUALIFICATIONS

• PhD degree in Virology, Microbiology, Cell biology, Biochemistry or related discipline with a minimum of 10 years related industry experience
• Experience in preclinical manufacturing and release of material with a working knowledge of both scientific and non-scientific aspects
• Experience directing a laboratory-based manufacturing and release team
• Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software
• Strong track record of accomplishments in successful manufacturing campaigns, including completion of all required documentation
• Experience working with multi-functional teams outside of a reporting structure
• Strong verbal and written communication skills

PREFERRED QUALIFICATIONS

• Practical experience with manufacturing an RNA vaccine of various technologies (mRNA, self-amplifying RNA, etc) from DNA template, to RNA drug substance and LNP drug product
• Deep understanding of the quality attributes of an RNA LNP vaccine

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

Standard laboratory conditions - sitting, standing, primarily lab based

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

40 hours per week.

Relocation support available

Work Location Assignment:Flexible

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