Field Application Specialist – Downstream Process
Job Summary The Downstream Processing Application Specialist plays a pivotal role in the biopharma industry in Pune, a growing hub for biotech and pharmaceutical companies. The specialist is responsible for developing, optimising, and implementing downstream processing (DSP) techniques to purify biopharmaceutical products such as monoclonal antibodies (mAbs), recombinant proteins, vaccines, or gene therapies. This role involves hands-on laboratory work, process troubleshooting, and collaboration with cross-functional teams to ensure high product yield, purity, and compliance with regulatory standards (e.g., cGMP). The specialist will provide technical expertise in a fast-paced environment, supporting Pune-based biopharma companies or contract development and manufacturing organisations (CDMOs). Key Responsibilities Process Development and Optimisation : Design and execute downstream unit operations, including chromatography (e.g., Protein A, ion exchange, hydrophobic interaction), filtration (e.g., tangential flow filtration, ultrafiltration/diafiltration), and viral clearance/inactivation. Conduct experiments at lab and pilot scales to develop scalable purification processes for biologics. Analyse process parameters (e.g., yield, purity, recovery) using tools like HPLC, UV-Vis spectroscopy, or SDS-PAGE to optimise performance. Equipment Operation and Troubleshooting : Operate downstream processing equipment, such as chromatography systems, TFF systems, and filtration units. Perform calibration, maintenance, and troubleshooting of DSP equipment to ensure operational efficiency. Support scale-up activities from lab to pilot or commercial manufacturing. Technical Support and Collaboration : Provide technical expertise to internal teams or external clients (e.g., during technology transfer or process validation). Work with upstream processing, analytical development, and quality assurance teams to integrate DSP workflows. Assist in training junior staff or clients on DSP techniques and equipment operation. Regulatory Compliance and Documentation : Ensure processes adhere to cGMP, Indian regulatory standards (e.g., CDSCO), and international guidelines (e.g., ICH, FDA, EMA). Prepare and review technical documents, including SOPs, batch records, process development reports, and validation protocols. Conduct risk assessments and implement corrective actions for process deviations. Process Innovation : Evaluate and implement advanced DSP technologies, such as single-use systems, continuous processing, or process analytical technology (PAT) tools (e.g., Raman spectroscopy). Contribute to cost reduction and process efficiency initiatives to meet production goals. Data Analysis and Reporting : Analyse experimental data using statistical tools or software to guide process improvements. Prepare technical reports and present findings to internal teams, management, or clients in Pune-based facilities. Qualifications and Skills Education : B.Tech/M.Tech in Biotechnology, Biochemical Engineering, Chemical Engineering, or a related field. A Ph.D. is a plus, but not mandatory. Experience : 4–6 years of hands-on experience in downstream processing within the biopharma or biotech industry. Proven expertise in purification techniques (e.g., chromatography, filtration) for biologics like mAbs, recombinant proteins, or vaccines. Experience with process development, scale-up, or tech transfer in a CDMO or biopharma setting is preferred. Technical Skills : Proficiency in operating DSP instruments such as TFF, Chrome or Depth Filtration. Familiarity with analytical techniques (e.g., HPLC, ELISA, UV-Vis) for process monitoring. Knowledge of cGMP environments and single-use technologies. Soft Skills : Strong problem-solving and analytical skills for process optimisation and troubleshooting. Effective communication skills for technical documentation and team/client interactions. Ability to work in a fast-paced, collaborative environment. Software Skills : Proficiency in Microsoft Office (Excel, Word, PowerPoint). Familiarity with statistical tools (e.g., Minitab, JMP) or process simulation software is a plus. Regulatory Knowledge : Understanding of cGMP, CDSCO, and international regulatory standards (e.g., FDA, EMA). Preferred Qualifications Experience with continuous manufacturing or single-use DSP systems. Familiarity with purification processes for gene therapies or viral vectors. Exposure to process characterisation or validation in a cGMP environment. Prior work with Pune-based biopharma companies or CDMOs. Work Environment Location : Based in Pune, Maharashtra, Work Setting : Laboratory and/or manufacturing facility with controlled environments (cleanrooms). May involve occasional client site visits within Pune or other major Biopharma hubs in India. Schedule : Standard business hours (Monday–Saturday), with flexibility for shift work during manufacturing campaigns or urgent project timelines. Safety : Adherence to biosafety protocols (e.g., PPE, handling biologics) and compliance with cleanroom standards. Salary and Benefits Salary : As per market standards. Negotiable. Travel Allowances will be as per the market. Benefits : Common benefits include: Health insurance. Provident fund (PF) and gratuity. Paid time off (PTO) and performance bonuses. Professional development opportunities (e.g., training, certifications). Some companies offer transport allowances or relocation support within Pune. Why Pune? Pune is a major hub for India’s biopharma industry, with proximity to Mumbai and a strong ecosystem of biotech companies, research institutes, and CDMOs. Companies like Serum Institute and Gennova drive demand for DSP specialists, particularly for vaccine and biosimilar production. The city’s infrastructure, including Hinjewadi IT and Biotech Park, supports a vibrant job market for bioprocess professionals.
