Job Description
The Biologics Process Research & Development organization within the Research & Development Division is responsible for developing the drug substance manufacturing processes for the company's biologics pipeline. The team works 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. The team is also responsible for late-stage process development and process characterization to prepare for commercial manufacturing, working with partners in the 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. In this role, a successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of the company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. They must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected.
Responsibilities include, but are not limited to:
•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.
Minimum Education Requirements:
•Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field
Required Experience and 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 objective under aggressive timelines.
•Proficiency in Bioreactor simulation and modeling.
Preferred Experience and 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.
Required Skills:
Biological Engineering, Biologics, Bioreactors, Biotherapeutics, Cell Biology, Cell Culture Bioreactors, Cell Culture Techniques, Cell Line Development, Chemical Engineering, CMC Development, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Mammalian Cell Culture, Molecular Biology, Patentability, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Characterization, Process Development (PD), Recombinant Protein Production, Recombinant Proteins, and one more.
Compensation
The primary location for this posting is USA - New Jersey - Rahway. The salary range for the primary location of this role is $142,400.00 - $224,100.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. 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. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Additional Details
•Employee Status: Regular
•Relocation: Domestic
•VISA Sponsorship: Yes
•Travel Requirements: 10%
•Flexible Work Arrangements: Not Applicable
•Shift: Not Indicated
•Valid Driving License: No
•Hazardous Material(s): n/a
