Pfizer

Research Fellow, PCMM PAT Program Lead

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
August 01 2021
Ref
4814116
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
The qualified candidate will take an active role in leading the process analytical technology aspects of Portable Continuous Miniature Modular (PCMM) manufacturing of Pfizer's drug products. This position requires a mixture of technical and strategic thinking, pharmaceutical continuous manufacturing experience, the ability to operate in a highly matrixed and technical environment with leadership and supervisory responsibilies. The position will appeal to those colleagues who thrive in a multifunctional team setting and who like to operationalize innovation creating new ways of doing analytical work. Technical experiences that would be needed in order to be successful in this role are knowledge of vibrational spectroscopy (NIR, IR, Raman etc) as well as general analytical method development and transfer operations and procedures (clinical and commercial). Additional requirements needed for the candidate to be successful in this role are competency in data analytics (chemometrics, modeling), as well as data and computer science. Experience in the pharmaceutical continuous manufacturing processes for drug substance and/or drug product and experience in a regulated environment would also be looked upon favorably. This position would contribute to and be part of the SPECTech Leadership Team and the ARD Team Leaders forum.

RESPONSIBILITIES

The individual will join the highly innovative and well established process analytical team that is leading the transition from batch to continuous manufacturing with appropriate integration of advanced sensors and process analytical technologies for both drug substance and drug product. The position will require the successful candidate to:
  • Lead the effort to innovate and integrate process analytical technology (in its broadest definition) solutions to the continuous manufacture of drug products and Advance our organizational vision to generate 50% of all our data in the in-line and on-line mode.
  • Lead the development of new sensor development to continue expanding our in-line toolbox.
  • Develop effective digital and data science strategies and drive alignment across the network.
  • Influence the regulatory landscape as appropriate to enable use of innovative approaches required to continue leveraging new technologies and realize the full potential of these tools.
  • Connect, collaborate and partner with analysts, formulators and drug product manufacturing colleagues to progress our clinical program development and execution strategies.
  • Lead the effort to establish alignment across our global PCMM network which includes technology and method transfers.
  • Use knowledge of product development and manufacturing to establish effective workflows that allow resource sharing across the network and enable seamless operation.
  • Effectively represent the group's accomplishments and efforts with both oral and written communication.
  • Be able to communicate and interact with colleagues and leadership at multiple levels. Be able to break down highly technical content into understandable and effective communications.
  • Mentor and train colleagues across the global organization as needed.
  • Has attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required both laterally and vertically within the organization and representing Pfizer, ARD and the SPECTech group outside of day to day responsibilities.
  • 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. in Analytical Chemistry with 15+ years' experience required with specialized knowledge of analytical chemistry, spectroscopy (NIR, Raman and IR).
  • Proficiency in some if not all of the data science disciplines such as chemometrics, multivariate analysis, Machine Learning, computer science with software and hardware integration.
  • Experienced spectroscopist with NIR, Raman, FTIR, UV spectroscopy with broad analytical chemistry hands on experience in the pharmaceutical industry.
  • Experience at developing, validating and transferring methods for application to continuous manufacturing and understanding of current regulatory environment are needed for this role.


PREFERRED QUALIFICATIONS
  • Preference is for powder and solids experience with continuous manufacturing processes.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Expect no more than 20% travel.


Other Job Details:
  • Eligible for Relocation Package: Yes
  • Eligible for Employee Referral Bonus: Yes


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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.

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