Scientist - Upstream Cell Culture, Bioprocess Design Center (Single-Use Facility)

Responsibilities:

• Develop and optimize upstream cell culture processes, including media formulation, feeding strategies, and bioreactor control parameters.
• Perform small-scale, bench-scale, and pilot-scale experiments to support process development and solving.
• Assess and incorporate single-use bioreactor systems and technologies to enhance process flexibility and efficiency.
• Design and complete experiments to enhance cell growth, productivity, and product quality attributes.

Technology Transfer and Scale-Up

• Lead upstream process technology transfer to clinical and commercial manufacturing scales.
• Develop and document detailed process descriptions, standard operating procedures (SOPs), and batch records for scale-up activities.
• Collaborate with manufacturing to ensure smooth implementation of upstream processes in single-use production systems.

Data Analysis and Documentation

• Analyze experimental data to evaluate process performance, identify trends, and recommend improvements.
• Prepare technical reports, presentations, and documentation for internal and external collaborators, following Good Documentation Practices (GDP).
• Maintain accurate records of process development activities and experimental results in electronic lab notebooks (ELNs).

Collaboration and multi-functional Support

• Work closely with downstream processing, analytical development, quality assurance, and regulatory teams to ensure seamless integration into end-to-end biomanufacturing workflows.
• Participate in project meetings and contribute to strategy discussions, ensuring alignment with organizational goals and timelines.
• Support solving and resolution of upstream-related challenges during production.
• Stay informed on advancements in cell culture technologies, single-use systems, and bioprocessing methodologies.
• Identify and implement innovative approaches to improve upstream process efficiency, scalability, and sustainability.
• Actively contribute to fostering a culture of innovation and continuous improvement within the Bioprocess Design Center.

Experience:

• Ph.D., M.S., or B.S. in Biotechnology, Biochemical Engineering, Molecular Biology, or a related field with a focus on cell culture and upstream processing.
• 3+ years of experience in upstream process development for biologics, including hands-on experience with mammalian or microbial cell culture systems.
• Proficiency in working with single-use bioreactor systems is highly preferred.
• Familiarity with fed-batch, perfusion, and continuous culture processes.
• Solid understanding of bioreactor design, operation, and process control strategies.
• Proficiency with process monitoring tools and analytical instrumentation for cell culture.
• Excellent problem-solving and analytical skills with the ability to manage sophisticated data sets.
• Strong written and verbal communication skills, with experience communicating technical data to diverse audiences.
• Experience with cGMP guidelines, regulatory standards, and technology transfer in biomanufacturing.
• Knowledge of cell line development and characterization.
• Familiarity with automation, PAT (Process Analytical Technology), and data-driven optimization tools.
• Lead numerous projects simultaneously and meet aggressive timelines.
• Demonstrated ability to lead multiple collaborators and conflicting goals.
• Business-level proficiency in English (verbal/written) and proficiency in Excel and presentation skills.
• Willingness to travel as required.
• Self-motivated, team-oriented, collaborative and skilled in working in a matrixed and multi-functional environment
• Good social skills (oral and written)