Senior Scientist - Product Development & Optimization; NPD&O

Job Purpose: The NPD&O Senior Scientist is responsible for driving innovation and operational excellence in upstream bioprocess development, with a specialized focus on advanced mammalian cell culture techniques. Serving as Leinco Technologies’ Subject Matter Expert (SME) in cell culture, this role is critical to delivering high-quality biotechnological products—including recombinant proteins and antibodies—efficiently, reliably, and at scale to support the organization’s scientific and commercial objectives.

Key Responsibilities:

• Lead Mammalian Cell Culture Development: Design, develop, and optimize robust mammalian cell culture bioprocesses (e.g., CHO, HEK
  293). Drive innovation in cell line development, clone selection, media screening, feeding strategies, and scale-up from shake flasks to large-scale bioreactors.
• Technology Transfer & Scale-Up: Facilitate the smooth transfer of developed mammalian cell culture processes from R&D bench-scale to pilot and commercial production, ensuring high cell viability, consistent titer, reproducibility, and rigorous performance validation.
• Process Optimization & Troubleshooting: Continuously analyze and troubleshoot critical cell culture parameters (e.g., dissolved oxygen, pH, metabolites, agitation) to optimize cell growth, improve target protein yield, reduce costs, and enhance overall process robustness.
• Cross-functional Collaboration: Partner closely with downstream purification, analytical, and manufacturing teams to ensure seamless process integration, maintaining critical quality attributes from the bioreactor through to final purification.
• Project Leadership: Serve as the technical lead on cross-functional development teams, managing timelines, deliverables, and scientific strategy specifically tailored to upstream mammalian bioprocessing.
• Upstream Process Management: Oversee upstream production operations, executing complex aseptic cell culture techniques across lab-scale, pilot-scale, and commercial-scale bioreactors (including fed-batch and perfusion systems) while ensuring strict alignment with GMP, quality, and safety standards.
• Resource & Facility Management: Oversee the planning and utilization of specialized cell culture equipment (e.g., automated bioreactors, cell counters, metabolic analyzers), consumables, and manpower in R&D and production; assist in budget planning and cost control.
• Documentation Compliance: Ensure all upstream activities comply with internal SOPs, the Quality Management System (QMS), and Quality Objectives; maintain meticulous records including batch records, cell banking documentation, development reports, and validation protocols.
• Reporting & Communication: Provide regular updates and data-driven presentations to senior management on cell culture metrics, project progress, and technical challenges; contribute to scientific publications and intellectual property generation where applicable.
• Additional: Perform other assigned duties within and outside of the department as needed to support business goals.

Minimum Qualifications:

• M.S. or Ph.D. in Cellular Biology, Bioengineering, Biotechnology, or a closely related scientific field.
• Deep technical expertise and significant hands-on experience in mammalian cell culture techniques, including aseptic processing, cell line maintenance/development, and bioreactor operations (e.g., stirred-tank, wave-mixed, fed-batch, perfusion).
• Strong proficiency in standard office software (Word, Excel) as well as familiarity with data analysis tools and bioprocess control software.
• Exceptional problem-solving skills with a proven track record of troubleshooting complex cell culture challenges, the ability to work independently, and meticulous attention to detail.