Associate Principal Scientist, Upstream Process Development

About the Role

The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. We are seeking a highly motivated and energetic individual to join our team as an Associate Principal Scientist.

Responsibilities

• Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
• Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
• Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keep current with the external literature environment; actively present and publish externally and pursue patenting strategies.

Qualifications

• Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field.

Required Skills

• Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale.
• Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
• Excellent verbal, written communication, and interpersonal skills.
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Productivity and efficiency working in the laboratory.
• Ability to deliver complex objectives under aggressive timelines.

Preferred Skills

• Experience with cell culture media development.
• Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
• Knowledge of biologics CMC development cycle and scale-up/down in addition to tech transfer to GMP manufacturing site.

Pay

The salary range for this role is $142,400.00 - $224,100.00. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits

We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.