Vastu Vihar Biotech Pvt. Ltd.
Website:
vvbiotech.com
Job details:
Job Description
Job Title: Senior Microbiologist - Commercial Scale Fermentation (GMP)
Location: Bodh Gaya, Bihar, India
Job Type: Full-time | On-site
Experience: 2-5 years in commercial-scale microbial production with a GMP environment
About Role :-
Vastu Vihar Biotech Pvt. Ltd. is scaling its microbial biomanufacturing platform from pilot to commercial scale. We are seeking an experienced Senior Microbiologist to lead the upstream production of aerobic, Gram-positive bacterial strains under cGMP conditions for our postbiotic, bacterial extracellular vesicle (bEV), and live biotherapeutic product pipelines.
The successful candidate will own the end-to-end microbiological aspects of commercial fermentation — from master and working cell bank management through seed train, production fermentation, harvest, and downstream handoff — while maintaining full compliance with cGMP, regulatory expectations (CDSCO, ICH Q7/Q11), and internal quality systems.
Key Responsibilities :-
Commercial-Scale Microbial Production
• Operate, monitor, and troubleshoot commercial-scale aerobic fermentation processes (typically 500 L to several thousand L stirred-tank bioreactors) for Gram-positive bacterial strains (e.g., Bacillus spp., Lactobacillus / Lactiplantibacillus spp., or comparable industrial strains).
• Manage the full seed-train workflow: cell bank thaw, shake-flask propagation, seed fermenters, and inoculation of production vessels.
• Optimize and execute critical process parameters — agitation, aeration, dissolved oxygen, pH, temperature, foam control, and feed strategy — to deliver consistent yield, viability, and product quality batch-to-batch.
• Lead scale-up and tech-transfer activities from lab (1–10 L) and pilot (50–200 L) to commercial scale, ensuring scale-independent performance.
Fermentation Process Optimization
• Lead systematic optimization of upstream fermentation processes to maximize biomass yield, productivity (g/L/h), product titre, viability, and batch-to-batch reproducibility.
• Design and execute Design-of-Experiments (DoE) studies — screening (Plackett-Burman, fractional factorial) and optimization (Box-Behnken, central composite, response surface methodology) — to characterize and refine critical process parameters.
• Optimize media composition (carbon and nitrogen sources, micronutrients, buffering, antifoam) and feed strategies (batch, fed-batch, continuous, pulse vs. exponential feeding) to support strain physiology and target product profile.
• Tune and control critical process parameters — agitation, aeration, dissolved oxygen, kLa, pH, temperature, redox, and CO2 stripping — across scales while preserving scale-independent performance.
• Apply statistical process control (SPC), multivariate data analysis (MVDA), and golden-batch comparison to identify drift, reduce variability, and tighten process capability (Cpk).
• Drive Quality-by-Design (QbD) workflows: define CQAs, link them to CPPs and CMAs, build the design space, and document control strategies for regulatory filings.
• Lead troubleshooting of yield deviations, viability loss, foaming, oxygen limitation, lysis, and contamination events, and convert root-cause findings into permanent process improvements.
• Own the cost-of-goods (COGS) reduction roadmap for upstream — media cost, cycle time, utility consumption, and labor — without compromising product quality or regulatory commitments.
GMP Compliance & Quality Systems:-
• Author, review, and execute SOPs, Batch Manufacturing Records (BMRs), and Master Production Records (MPRs) for all microbiological operations.
• Ensure full cGMP compliance across personnel hygiene, gowning, aseptic technique, cleanroom behavior, and environmental monitoring.
• Handle deviations, OOS/OOT investigations, CAPAs, and change controls through the site Quality Management System.
• Support internal, customer, and regulatory audits (CDSCO, WHO-GMP, EU-GMP, US-FDA-style inspections) as the subject-matter expert for upstream microbiology.
• Maintain audit-ready documentation: cell bank histories, batch records, environmental monitoring trends, equipment logs, and training records.
Microbiological Control & Environmental Monitoring
• Design and oversee the environmental monitoring (EM) program for classified areas (Grade A/B/C/D) — viable air, non-viable particulate, surface, and personnel monitoring.
• Manage bioburden, sterility, endotoxin (LAL), and identity testing programs in coordination with QC Microbiology.
• Investigate and resolve microbial contamination events, OOS results, and trend deviations.
• Lead phenotypic and genotypic strain identity verification (Gram staining, biochemical panels, 16S rRNA sequencing, MALDI-TOF, where applicable).
Cell Bank & Strain Management
• Manage Master and Working Cell Bank (MCB/WCB) preparation, qualification, storage, and stability monitoring.
• Maintain strain genealogy records and ensure traceability across all production campaigns.
• Coordinate with R&D on new strain introduction, qualification, and lifecycle management.
Equipment, Validation & Continuous Improvement
• Own user-side responsibilities for IQ/OQ/PQ of fermenters, autoclaves, biosafety cabinets, and associated upstream equipment.
• Drive process validation (PPQ), cleaning validation, and ongoing process verification (continued process verification – CPV) for microbial production lines.
• Identify and implement yield, robustness, and cost-of-goods improvements through DoE, statistical process control, and lean manufacturing principles.
• Train and mentor production microbiologists, technicians, and operators.
Required Qualifications :-
• Education: M.Sc. / Ph.D. in Microbiology, Industrial Microbiology, Biotechnology, Bioprocess Engineering, or a closely related discipline.
• Gram-positive expertise: Demonstrable production experience with aerobic Gram-positive bacteria (e.g., Bacillus subtilis, B. velezensis, B. licheniformis, B. coagulans, Lactiplantibacillus / Lacticaseibacillus species, or comparable industrial Gram-positive strains).
• Aerobic fermentation: Strong, demonstrated track record with aerobic submerged fermentation — including oxygen transfer (kLa) management, foam control, and feed-batch / fed-batch operation.
• Process optimization: Proven hands-on experience optimizing commercial fermentation processes — DoE / RSM, media and feed strategy design, CPP–CQA linkage, and statistical analysis of process data.
• GMP facility experience: Mandatory. Must have worked in an operational GMP-licensed manufacturing facility (pharma, biopharma, vaccine, probiotic, or food-grade biotech) and be conversant with cGMP documentation, deviations, CAPA, and audit handling.
• Regulatory familiarity: Working knowledge of CDSCO requirements; exposure to WHO-GMP, EU-GMP, USFDA, or PIC/S frameworks is required for senior candidates.
• Technical skills: Aseptic technique, EM program design, sterility assurance, microbial identification methods, basic statistical analysis, and competent use of MS Office / electronic batch record systems.
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