Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

At Thermo Fisher Scientific, you'll be part of a collaborative team working towards building a better world. As a global leader, we provide the support and opportunities you need to make a significant difference.

As a Scientist specializing in Upstream Cell Culture, you will apply your expertise in mammalian, microbial, or other cell culture systems. You will design robust upstream processes to contribute to the development of biopharmaceutical products.

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.

• 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.

• 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).

• 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.

• 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)