Biomolecules Downstream Processing Specialist

Company Description

Sanzyme Biologics is a pioneering company specializing in probiotics and fermentation-derived nutritional ingredients. Established in 1969 as Uni-Sankyo, the company has become a global leader in producing high-quality, shelf-stable probiotic strains and enzymes used in various industries, including food, pharmaceuticals, and agriculture. With over 50 years of expertise, Sanzyme Biologics delivers science-backed products trusted by customers in over 40 countries, supported by state-of-the-art manufacturing facilities in Hyderabad, India. The company holds globally recognized certifications, including ISO, GMP, Halal, and Kosher, ensuring stringent quality and safety standards. Sanzyme Biologics is committed to advancing human and animal health with innovative solutions that enhance lives.

Role Description

This is a full-time, on-site role for a Biomolecules Downstream Processing Specialist based in Telangana, India. The responsibilities include downstream processing specialist with extensive experience in the purification of recombinant proteins, enzymes, peptides, and biologics (expressed in Escherichia coli etc.). Skilled in designing, optimizing, and scaling purification processes from bench to commercial manufacturing under cGMP conditions. Demonstrated expertise in inclusion body handling, refolding strategies, chromatographic purification, filtration technologies, and process characterization.

Primary Recovery

• Cell harvest optimization (centrifugation, microfiltration)
• High-efficiency cell lysis: homogenization, sonication, chemical and enzymatic lysis
• Inclusion body isolation, washing, and solubilization

Protein Refolding & Solubilization

• Chaotropic agent–based solubilization (urea, guanidine HCl)
• High-throughput screening of refold conditions
• Redox-controlled refolding for disulfide-bonded proteins

Chromatography Expertise

• Affinity (His-tag, GST, Protein A/G, IMAC)
• Ion exchange (IEX)
• Hydrophobic interaction (HIC)
• Size-exclusion (SEC)
• Mixed-mode chromatography
• Development of multistep purification trains

Filtration Technologies

• Microfiltration (MF) and ultrafiltration/diafiltration (UF/DF)
• Buffer exchange and concentration operations
• Scaling membrane processes (flat sheet, hollow fiber, TFF)

Process Development & Scale-Up

• Design of experiments (DoE)
• Process robustness studies
• Viral inactivation (where applicable), endotoxin control strategies
• Tech transfer to pilot/commercial sites

Quality & Regulatory

• cGMP operations
• Documentation: batch records, SOPs, validation protocols
• Purity, potency, and impurity profiling
• Endotoxin reduction strategies & QC methods

Qualifications

• Expertise in downstream processing techniques such as chromatography, filtration, centrifugation, and precipitation
• Hands-on experience with quality control processes and analytical testing methods
• Demonstrated ability in process optimization and troubleshooting in a biopharmaceutical or biotechnology setting
• Knowledge of regulatory and compliance standards in manufacturing environments
• Strong analytical thinking, problem-solving skills, and attention to detail
• Effective collaboration skills and ability to work in multidisciplinary teams
• Educational background in Biotechnology, Biochemistry, or relevant life sciences field; Master’s degree or equivalent is an advantage
• Prior industry experience in probiotics, fermentation, or related fields is a plus