Sr. Manager, Upstream Process Development
1 month ago
Job Scope:
The Sr. Process Development Upstream Manager is a critical contributor to our organization. This role involves scouting for technology, providing insights for strategic technology selection, and leading its implementation within GenScript ProBio's CGT business unit. The incumbent is expected to develop project plans and timelines and manage the development and optimization of upstream processes for plasmid DNA production to reduce development cycle times and improve cost-effectiveness (COGs). This position requires a deep technical background in upstream microbial fermentation processes and extensive hands-on experience. The successful candidate will lead a team of senior scientists, driving process development, optimization, PreCMC and CMC production, new technology development, and technology transfer to deliver high-quality work to clients.
Position Information:
Work Location: Pennington, NJ
Reports to: Head of PD
Roles and Responsibilities:
• Lead a matrix group to develop, improve, troubleshoot, and implement scalable high-yielding processes using novel and/or existing technologies for plasmid DNA, and related new modalities to support early and late-stage cell and gene therapy programs.
• Supervise, mentor, and train a team of senior scientists and scientists for upstream process development in fermentation, bench-scale, and scale-up to MFG large-scale single-use fermenters for plasmid DNA production.
• Oversee and execute experiment design, execution, analysis, and reporting for clients and internal programs using microorganisms to develop and improve cell lines and fermentation production processes.
• Assess and adopt new methods, techniques, and technology platforms, including equipment demonstrations, to continually enhance the upstream process. Stay abreast of the latest developments in upstream processes for plasmid DNA production.
• Play a key role in technical transfer, including scale-up activities, proposal and statement of work (SOW) reviews, and person-in-plant support as needed.
• Author, review, and edit detailed process descriptions and technical reports to document study outcomes and justify process changes and/or process updates. Prepare technical reports, documentation for regulatory submissions, and standard operating procedures (SOPs) based on your extensive knowledge and best practices.
• Collaborate and maintain open communication with colleagues in downstream, analytical, quality control (QC), quality assurance (QA), and manufacturing departments, ensuring they are well-informed about upstream projects.
• Foster a collaborative and results-oriented team environment, leveraging your wealth of experience to guide and support team members. Establish performance expectations based on your deep expertise, conduct regular performance reviews, and provide constructive feedback.
• Develop and implement advanced quality control procedures, drawing from your expertise, to monitor product quality throughout the upstream process.
• Maintain comprehensive records of all upstream processing activities, ensuring data accuracy and traceability.
• Gain understanding of company operations and interdepartmental interactions to improve workflow and system optimization.
Qualifications:
• Ph.D. (5+ years), MS (8+ years), or BS (10+years) in a biological or engineering discipline (chemical engineering, biochemistry, molecular biology, or equivalent) plus 10+ years of relevant experience, including biologics upstream process development, process characterization, cell biology, and plasmid DNA research.
• Expertise in fermentation, cell culture, suspension bioreactor from 3 liters up to 300 liters, process scaling (scale up/scale down), single-use technologies, media development, cell line development, filtration, analytical methods, and knowledge of plasmid DNA or viral vectors.
• Experience with late-stage process characterization work, including FMEA, DOE studies, and development of process control strategies.
• Expertise with JMP, Minitab, or similar statistical software, and fermentation automation and process control software system(SCADA), specifically BioCommand and DeltaV software.
• Proven experience in team leadership and project management.
• Excellent problem-solving, troubleshooting, and written/verbal communication skills.
• Demonstrated ability to drive toward results and generate innovative solutions. Applicants should be self-motivated, organized, and capable of working independently and in a collaborative environment.
• Strong interpersonal skills (job could require customer/peer/senior management interaction) and ability to work effectively on teams.
• In-depth knowledge of regulatory requirements and quality compliance within the biopharmaceutical industry.
• Familiarity with GMP and GLP regulations is a plus.
• An understanding of end-to-end process for cell and gene therapy manufacture.
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