Senior Scientist
Fermentation Process Development

About the Role

As Senior Scientist in Fermentation Process Development, you will design, optimise, and scale up fermentation processes for active pharmaceutical ingredient (API) manufacturing at our Hosur Campus. Working within a cross-functional team of biochemists, process engineers, and downstream processing specialists, you will be instrumental in translating laboratory findings into robust, cGMP-compliant commercial processes.

This is a high-impact role with direct responsibility over new product introductions and process improvement initiatives serving EU, UK, and global markets.

Key Responsibilities

• Design and execute fermentation process development experiments for microbial and fungal systems, optimising media, pH, dissolved oxygen, temperature, and feed strategies
• Lead scale-up from bench (2–5 L) through pilot (200 L) to commercial scale (10,000 L+), ensuring process robustness and reproducibility at each stage
• Conduct Design of Experiments (DoE) using JMP or Minitab to identify critical process parameters (CPPs) and establish proven acceptable ranges (PARs)
• Develop and validate in-process control methods in collaboration with QC Analytical Chemistry teams
• Author process development reports, tech transfer documents, and CTD Module 3 sections for regulatory submissions (MHRA, EMA, TGA)
• Collaborate with Downstream Processing on integrated upstream–downstream process design to maximise yield and purity
• Support manufacturing tech transfer, provide on-floor guidance during initial commercial batches, and investigate deviations
• Drive continuous improvement initiatives to increase titre, yield, and cost efficiency across existing commercial processes
• Mentor junior scientists and guide their experimental planning and data analysis

Qualifications & Experience

• M.Sc. or Ph.D. in Biochemical Engineering, Microbiology, Biotechnology, or a related discipline
• 5–8 years of hands-on experience in fermentation process development within pharmaceutical, biotech, or contract manufacturing
• Demonstrated experience with microbial fermentation (E. coli, Bacillus, Aspergillus, or similar) and/or mammalian cell culture
• Proficiency in bioreactor operations — Sartorius BIOSTAT, Applikon, or equivalent systems; skilled in online sensor management and control strategies
• Hands-on experience with PAT tools including off-gas analysis, Raman spectroscopy, and at-line metabolite monitoring
• Strong knowledge of cGMP requirements for API manufacturing; familiarity with ICH Q8, Q9, Q10 guidelines
• Experience preparing regulatory documentation (CMC sections, tech transfer protocols) is highly desirable
• Excellent analytical, problem-solving, and scientific communication skills