Downs Stream Application Scientist Full-time

Scientist Specializing In Downstream Process

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 Downstream process, you will apply your expertise in mammalian, microbial, or other purification systems. You will design robust downstream processes to contribute to the development of biopharmaceutical products.

Responsibilities:

• Develop and optimize Downstream processes, including chromatography process for customer projects or in-house process development
• Perform small-scale, bench-scale, and pilot-scale experiments to support process development and solving.
• Assess and incorporate resin 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 downstream 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)

At Thermo Fisher Scientific, our goal is to empower our customers to make the world a better place by promoting health, cleanliness, and safety. As a distributed team with over 125,000 colleagues, we uphold the values of Integrity, Intensity, Innovation, and Involvement. Together, we advance research, solve sophisticated scientific problems, develop technological innovation, and provide support to those in need. Join our diverse and inclusive community at Thermo Fisher Scientific.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

ThermoFisher is committed to crafting a diverse work environment that values and respects individuals from all backgrounds. ThermoFisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.