Job Purpose:
The NPD&O Senior Scientist is responsible for driving innovation and operational excellence in upstream bioprocess development and production within Leinco Technologies, Inc. The goal is to deliver high-quality biotechnological products efficiently, reliably, and at scale to support the organization’s scientific and commercial objectives.
Key Responsibilities:
1. Lead Upstream Process Development: Design, develop, and optimize robust cell culture and upstream bioprocesses, including strain improvement, media optimization, and process scalability.
2. Technology Transfer: Facilitate smooth transfer of developed upstream processes from R&D to production, ensuring reproducibility, documentation accuracy, and performance validation.
3. Process Optimization & Troubleshooting: Continuously analyze, optimize, and troubleshoot upstream processes to improve yield, reduce cost, and enhance process robustness and consistency.
4. Cross-functional Collaboration: Partner closely with downstream, analytical, and manufacturing teams to ensure seamless process integration and technology transfer.
5. Project Leadership: Serve as a technical lead on cross-functional development teams, managing timelines, deliverables, and scientific strategy for upstream development.
6. Upstream Process Management: Facilitateupstream production operations including lab-scale, pilot-scale, and commercial-scale cell culture, ensuring alignment with GMP, quality, and safety standards.
7. Resource & Budget Management: Oversee planning and utilization of equipment, consumables, and manpower in upstream operations and R&D; assist in budget planning and cost control.
8. Documentation Compliance: Ensure all activities comply with internal SOPs, Quality Management System (QMS), and Quality Objectives; maintain accurate records including batch records, development reports, and validation documents.
9. Reporting & Communication: Provide regular updates and presentations to senior management on project progress, production metrics, and technical issues; contribute to scientific publications and intellectual property generation where applicable.
10. Additional- Performing other assigned duties within and outside of department.
Minimum Qualifications:
1.M.S, in Biology or a related science field.
2.Previous experience within a Research laboratory setting.
3.Computer skills in Word and Excel.
4.Problem solving skills, ability to work independently, and detail oriented.
