Principal Scientist / Engineer Manufacturing Sciences and Technology

Role Summary

Manufacturing Sciences and Technology (MSAT) at Pfizer is looking for a highly motivated, versatile candidate to join our multidisciplinary team of scientists and engineers in Andover, MA. The group supports Pfizer's portfolio of late-stage development and commercial biopharmaceuticals and vaccines, and is responsible for process troubleshooting, process improvements and second- generation process development. We are looking for someone who is eager to contribute independent thinking and technical excellence to the upstream fermentation team.

The ideal candidate should have a solid understanding and experience with all fermentation operations for bioprocessing macro-molecules such as peptides, proteins and polysaccharides. The candidate must be able to lead the design, execution and interpretation of complex studies requiring highly organized data collection and management. The role is well-integrated with the rest of the MSAT group and will involve extensive collaborative work both within the group and across the Andover site.

The incumbent will serve as a primary technical expert for fermentation processing, will be responsible for designing and execute bioreactor experiments in bench-top & 15L bioreactors along with the associated scale-down equipment with the goal of developing robust, scalable, and high productivity processes that produce biotherapeutics with appropriate product quality attributes to treat human diseases.

The candidate will additionally collaborate with manufacturing operations in process improvement & robustness initiatives and technical investigations as a subject matter expert to ensure product supply. The colleague also be involved in leading innovation and technology development projects that seek to improve production processes both from a process engineering as well as a biological perspective that have the potential to increase process performance.

As the team supports multiple manufacturing teams in complex troubleshooting activities, it is expected that the candidate be a proficient user of problem-solving and risk analysis tools, and have a strong understanding of regulatory environment impacted by change or deviations. It is highly desirable that the candidate is a routine practitioner of the Lean/Six Sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc

ROLE RESPONSIBILITIES

• Work effectively in a fast-paced, customer-oriented, laboratory environment to develop and deliver process technology in support of commercial fermentation operations.
• A key member of the MSAT Andover Upstream Processing Team with responsibilities for leading the fermentation processes and technologies
• Lead the fermentation team members in creation and execution of complex experimental designs, and oversee interpretation of large data sets, including multifactorial experimental design
• Assist with manufacturing investigations and process troubleshooting
• Assist with technology transfers to cGMP facilities
• Contribute to integrated resource planning tools (facility, equipment, personnel) for periods of 12 m (tactical)
• Ensure a Continuous Improvement Mindset within the Upstream team
• Maintain the depth and scientific capability of the fermentation Team. Promote and drive the technical and personal development of peers and juniors
• Collaborate with Global CMC in preparation of relevant CMC sections for regulatory filing
• Drafting regulatory responses to queries from health authorities
• Ensure the group work safely at all times. Stay current with, and apply, all good work safety practices as recommended by the Andover site, the Biopharma Operating unit, and the company

Qualifications

• PhD with 4+ years, MS with 8+ years, or BS with 10+ years of experience in a scientific / technical role within the biotech industry supporting the development and commercialization of therapeutic recombinant proteins or vaccines
• Previous experience in designing and executing components of major experimental programs for biologics drug substance production in the laboratory or pilot-plant setting.
• Proficient user of problem-solving, risk analysis and statistical tools
• Highly proficient in common upstream bioprocessing tools with considerable experience in associated transfer and scale up. Knowledge of all aspects of fermentation, including batch, fed-batch, perfusion and harvest/clarification operations; control and data acquisition systems.
• Prior experience developing and maintaining scale down models of commercial biopharmaceutical processes
• Proficient in benchtop bioreactor operation and associated analytical tools (required)
• Experiencewith bench scale cell culture and/or bacterial fermentation (required)
• Prior experience in developing commercially relevant fermentation processes to produce pharmacologically active molecules Experienced in use of Design of Experiment (DoE) methodology and associated software (JMP, MiniTab) and other statistical tools
• Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry.
• Experience in drafting regulatory dossiers for agency submission

Preferred Qualifications

• Experience in supporting scale-up and technology transfer to pilot or commercial scale facilities
• Experience with protein and carbohydrate chemistry is strongly desired
• Proficient in benchtop and up to 20 L Steam in place bioreactor operations
• Strong statistics and programming background with proven experience delivering on data science, applications of machine learning a plus
• Demonstrated experience developing or introducing new technology into commercial processes

PHYSICAL/MENTAL REQUIREMENTS

• The position involves working in a laboratory which may include standing for long periods of time and working with potential biohazards.
• The position requires the ability to gather, analyze, interpret, relate, and compare information from multiple sources and identify complex cause and effect relationships.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Will likely require some out of hours working to support laboratory activities and teleconferences with other global sites
• Travel is expected for this role (~10% time)

Relocation support available

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