Senior Scientist, Culture Process Development

What You Will Achieve

A Senior Scientist (R4) position is available in the Upstream Process Development group within the Bioprocess R&D organization. The successful applicant will join a team of scientists and engineers focused on developing and optimizing manufacturing processes for recombinant proteins and other modalities for early- and late-phase human clinical trials. In this role, the candidate will be responsible for designing and executing laboratory experiments in bench-top bioreactors and associated scale-down equipment with the goal of developing robust, scalable, and high productivity processes. The work will also involve collaborating with pilot, clinical, and commercial production facilities to ensure accurate technology transfer, successful large-scale production and associated regulatory filing activities. The candidate may also be involved in cutting edge technology development projects that seek to improve production processes and control strategies leveraging various process analytical technologies.

How You Will Achieve It

• Design and execute experiments in appropriate scale-down models in an effort to develop robust, high yield, and scalable manufacturing processes

• Serve as upstream technical lead; ensure accurate technology transfer to pilot and GMP manufacturing facilities; provide technical support during manufacturing campaign as needed

• Timely and accurately document data in electronic lab notebooks; author technical reports and contribute to relevant sections of regulatory submissions such as IND and BLA

• Participate and contribute to discussions in lab and project team meetings on design of experiments and interpretation of data

• Contribute to safe, efficient, and harmonious lab environment; strong lab citizen and collaborative team player

• Occasionally work over the weekend to passage flasks, sample bioreactors or perform other essential tasks

QUALIFICATIONS

Must Have

• PhD degree with 0-3 years of experience in biotechnology/biopharma industry or Master's Degree with 7+ years of post-graduate experience or BA/BS with 9+ years of experience with a degree in Chemical/Biochemical Engineering, Bioengineering, Biotechnology, Cell Biology, Microbiology or relevant field

• Experience in development and characterization of cost effective, scalable mammalian cell culture processes for therapeutics production; process intensification and continuous manufacturing; Scale-up/scale-down of cell culture processes

• Good understanding of reactions involved in metabolic pathways and process kinetics in mammalian cells

• Competency in aseptic laboratory technique, ability to design complex experiments, analyze and interpret data

• Self-motivated, organized, and capable of working independently and in a collaborative environment and should have demonstrated ability to drive projects by coming up with innovative solutions

• Demonstrates strong attention to detail, and strong oral and written communication skills

• Has ability to work in a fast-paced team environment with changing priorities

• Demonstrated effectiveness in collaborative projects, and ability to communicate effectively with scientists and management in a highly matrixed organization

• Demonstrated passion for innovation and a creative approach to developing new technologies

Nice To Have

• Expertise in perfusion bioreactor operations, including process setup, control, troubleshooting of mammalian cell culture processes

• Hands-on experience with high-throughput bioreactor platforms, including ambr15 and ambr250 systems

• Expertise in process modeling, CFD, multivariate data analysis, and AI/ML-based predictive modeling to support process characterization and enhance process understanding

• Proficiency in Python programming, workflow automation, and software/app development to create scalable tools for experimental design, data processing, advanced analytics, visualization, and knowledge-sharing across process development organizations

PHYSICAL/MENTAL REQUIREMENTS

• Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• May require occasional work on the weekend for cell culture process-related essential tasks

• May need to travel occasionally to attend internal meetings or external conferences

Other Job Details

• Work Location Assignment: On Premise

• Eligible for Employee Referral

Relocation support may be available based on business need and eligibility

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.