AGM_ Upstream Process development

USV PRIVATE LIMITED; Maharashtra; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

USV PRIVATE LIMITED is seeking an experienced leader to head downstream process development for recombinant therapeutic proteins. The role focuses on directing a team, driving technology transfer to manufacturing, and ensuring regulatory compliance across global standards.

The incumbent will manage end-to-end projects, guide DoE-driven process characterization, and collaborate with upstream, QA, RA, and manufacturing teams to deliver scalable, compliant purification processes.

Qualifications

• Ph.D. or Master’s degree in Biotechnology/Biochemical Engineering or related Life Sciences.
• Hands-on supervisory experience in downstream lab and biotech R&D.
• Experience leading teams in biomanufacturing/biotech R&D.

Responsibilities

• Lead, mentor, and supervise scientists in downstream process development.
• Oversee projects from conceptualization to execution in the development pipeline.
• Guide scale-up/scale-down modeling and process characterization (DoE).
• Lead technology transfer to manufacturing facilities.
• Prepare and review process development reports, SOPs, and regulatory filings.
• Manage departmental infrastructure, equipment lifecycle, and budgeting.
• Ensure compliance with global regulatory guidelines (ICH, FDA, EMA).

Skills

Team leadership

Project management

Tech transfer

Process development

Regulatory knowledge

Technical writing

Troubleshooting

Cross-functional collaboration

Education

Ph.D. in Biotechnology

M.Tech / M.Sc. in Biotechnology

Job description

Role Objective

To lead and direct a team of scientists in downstream process development for recombinant therapeutic proteins. The incumbent will oversee multiple candidate product projects, drive technology transfer to manufacturing facilities, ensure strict regulatory compliance.

Key Responsibilities

• Team Leadership: Lead, mentor, and supervise scientists executing downstream process development activities, fostering a culture of technical excellence and continuous learning.
• Project Oversight: Manage and oversee projects in the process development pipeline for candidate recombinant therapeutic proteins from conceptualization to execution.
• Process Engineering: Guide and execute scale-up, scale-down model validation, and comprehensive process characterization activities.
• Technology Transfer: Lead the seamless technology transfer of developed downstream processes to commercial manufacturing facilities.
• Documentation & Compliance: Author, review, and approve critical process development reports, technology transfer dossiers, and standard operating procedures (SOPs).
• Infrastructure & Resource Management: Maintain departmental infrastructure, plan equipment lifecycle, and contribute to optimal resource allocation and budgeting.
• Regulatory Alignment: Maintain an up-to-date, deep understanding of global regulatory and compliance guidelines (e.g., ICH, FDA, EMA), ensuring all development practices strictly adhere to these standards.

Stakeholder Interaction

Type of Interaction: Internal

• Interaction with: Cross-functional teams including Upstream Process Development, Analytical Development (ADL), Quality Assurance (QA), Regulatory Affairs (RA), and Manufacturing Operations.
• Nature of Interaction: Collaboration on project requirements, project timelines alignment, troubleshooting development challenges, and coordinating technology transfer protocols.

Type of Interaction: External

• Interaction with: External vendors, technology partners, Contract Development and Manufacturing Organizations (CDMOs), and equipment suppliers.
• Nature of Interaction: Sourcing advanced downstream technologies, managing external development projects, and evaluating state-of-the-art purification infrastructure.

Job Requirements

Professional Experience and Relevant Skills

• Experience: Ph.D. with 8 to 12 years of relevant industrial experience in biomanufacturing/biotech R&D.
• Master’s degree (M.Sc. / M.Tech) with 12 to 15 years of relevant industrial experience.
• Must possess mandatory, hands‑on, and supervisory experience working in downstream lab

Technical Expertise

• Deep understanding of protein purification techniques (Chromatography: Affinity, IEX, HIC, SEC, Filtration: TFF, Depth filtration, Nanofiltration).
• Proven expertise in Scale-up/Scale-down modeling and Process Characterization (DoE approaches).
• Strong knowledge of tech transfer methodologies into cGMP environments.

Skills

• Excellent technical writing skills (protocols, reports, SOPs, and regulatory filings).
• Strong project management and resource allocation capabilities.
• Adept at troubleshooting complex downstream process deviations.

Academic Qualifications & Certifications

• Educational Qualification: Ph.D. or Master’s degree (M.Tech / M.Sc.) in Biotechnology, Biochemical Engineering, Biochemistry, or a closely related Life Sciences discipline.