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Associate Research Fellow, Group Leader, Purification Process Development

Pfizer, Inc.

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Andover, MA
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Job Description

As posted by the hiring company

Job Overview:

Role Summary

An Associate Research Fellow position is available within the Purification Process Development (PPD) group in Bioprocess R&D. The successful applicant will be responsible for leading a team of scientists and engineers focused on developing innovative, robust, efficient, and scalable purification processes and technologies required for the advancement of a diverse and extensive portfolio of large molecules including proteins and vaccines. They will be expected to provide strong technical, strategic and organizational leadership so as to ensure efficient and timely execution of PPD 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 Associate Research Fellow will work closely with other leaders in the PPD 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 for proteins and vaccines derived from mammalian and microbial expression; 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 Associate Research Fellow (Group Leader/Director Level) role is responsible for planning and developing colleagues throughout PPD, identifying growth opportunities and mentoring so that all staff can realize their full potentials, as well as dealing with performance issues appropriately. 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 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).
  • Familiarity with in-silico modeling applications applied to biological manufacturing processes and development
  • 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.
  • 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.

BASIC QUALIFICATIONS

  • Ph.D. degree in Chemical/Biochemical Engineering, Biochemistry, or equivalent with 15+ years of experience in a purification process development.

PREFERRED QUALIFICATIONS

  • Over 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.

Other Job Details:

  • Eligible for Employee Referral
  • Eligible for Relocation Package
  • Work Location Assignment: Flexible

#LI-PFE

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