Job Summary

We are looking for an experienced Downstream Processing (DSP) Expert with over 10 years of relevant experience in biopharmaceutical and biotechnology process development. The candidate should have hands-on expertise in downstream process development for peptides, monoclonal antibodies (mAbs), and biosimilars, along with a robust understanding of patent-related considerations, regulatory requirements, and process optimization.

The candidate will be responsible for developing, optimizing, and supporting robust downstream purification processes to ensure product quality, purity, yield, scalability, and regulatory compliance.

Key Responsibilities

- Develop, optimize, and scale up downstream processing and purification processes for peptides, monoclonal antibodies (mAbs), and biosimilars.
- Design and execute purification strategies involving chromatography, filtration, ultrafiltration, diafiltration (UF/DF), and other relevant separation techniques.
- Perform process development studies to improve product yield, purity, recovery, and overall process efficiency.
- Support laboratory-scale development, pilot-scale studies, technology transfer, and process scale-up activities.
- Develop and optimize process parameters, including buffer conditions, pH, conductivity, flow rates, and loading capacities.
- Characterize process impurities, product-related variants, and critical quality attributes (CQAs).
- Ensure downstream process activities comply with GMP requirements, applicable regulatory guidelines, and internal quality standards.
- Prepare and review technical documents, development reports, batch records, protocols, and process validation-related documents.
- Collaborate with upstream processing, analytical development, quality assurance, quality control, and regulatory affairs teams.
- Evaluate process feasibility, troubleshoot technical challenges,



and implement process improvements.
- Understand patent landscapes, intellectual property considerations, and freedom-to-operate requirements relevant to process development.
- Support regulatory submissions and provide technical inputs for CMC documentation, as applicable.

Required Qualifications

- M.Sc. / M.Tech. / M.Pharm. / Ph.D. in Biotechnology, Biochemistry, Bioprocess Engineering, Chemical Engineering, or a related discipline.
- 10+ years of relevant experience in downstream processing, biopharmaceutical purification, or process development.
- Hands-on experience with peptides, monoclonal antibodies (mAbs), and/or biosimilars.
- Strong knowledge of chromatography techniques, filtration systems, protein purification, and process optimization.
- Understanding of GMP, regulatory requirements, process characterization, and technology transfer.
- Familiarity with patent-related considerations and intellectual property requirements in biopharmaceutical development.

Required Skills

- Strong technical and analytical problem-solving skills.
- Expertise in downstream process development and purification technologies.
- Experience in process scale-up, optimization, and troubleshooting.
- Good technical documentation and report-writing skills.
- Ability to work collaboratively across cross-functional teams.
- Strong communication, planning, and project management skills.

Preferred Experience

- Experience in developing purification processes for therapeutic proteins, peptides, mAbs, and biosimilars.
- Exposure to process validation, comparability studies, and regulatory submissions.
- Experience working in biotechnology, biopharmaceutical R&D;, or biologics manufacturing environments.
- Knowledge of process economics, yield improvement, and cost optimization.

Pay: ₹50,000.00 - ₹80,000.00 per month

Benefits:

- Food provided
- Health insurance
- Leave encashment
- Paid time off

Work Location: In person

📌 Downstream - Expert (Pragathi Nagar)
🏢 Amogen Pharma
📍 Pragathi Nagar