Downstream Application Scientist
- Hyderabad, Telangana Andhra Pradesh
- Permanent
- Full-time
- Develop and optimize Downstream processes, including chromatography process for customer projects or inhouse 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.
- 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.
- 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)