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About Intas

Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations. The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world.

Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare. The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world.

Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA. Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare.

At Intas, our success is fundamentally built on the strength of our people. Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence. This approach ensures that every employee plays a meaningful role in driving both the company’s growth and advancements in global healthcare.

Job Title:  Asst. General Manager - DSP

Job Requisitions No.:  12607
Job Description: 

Purpose of Job

To lead and drive the downstream process development of biosimilar products, ensuring robust, scalable, and regulatory-compliant manufacturing processes from early development through clinical and commercial stages. This includes managing scientific teams, overseeing technology transfer, process characterization, and aligning development activities with project goals and regulatory expectations.

Skill Required

  • Strong expertise in downstream process development of biologics (chromatography, filtration, virus clearance, etc.)

  • Hands-on experience with scale-up, tech transfer, and process validation

  • In-depth knowledge of QbD principles, process characterization, and statistical tools

  • Familiarity with regulatory guidelines (ICH, FDA, EMA) and CTD documentation

  • Leadership and team management skills with ability to mentor junior scientists

  • Experience in cross-functional collaboration with MSAT, DPD, Regulatory, and IP teams

  • Strong documentation skills for protocols, reports, and regulatory filings

  • Working knowledge of cleaning validation and reuse studies (resin/TFF)

  • Proficiency in project planning, risk mitigation, and meeting deadlines

Roles and Responsibilites

1. Team Management & Leadership

  • Lead a team of scientists by setting goals, monitoring performance, and providing continuous feedback.

  • Build a technically strong downstream development group with expertise in biologics purification.

2. Downstream Process Development

  • Oversee development and optimization of downstream processes for biosimilar products.

  • Support engineering batches, clinical trial (CT) campaigns, and consistency batches.

  • Drive virus validation studies, process improvement initiatives, and robustness studies.

3. Technology Transfer & Scale-Up

  • Ensure smooth technology transfer from development to manufacturing.

  • Collaborate with MSAT and production teams for commercial manufacturing readiness.

4. Process Characterization & Validation

  • Conduct process characterization using QbD approaches and process capability studies.

  • Lead cleaning validation and reuse studies for resins and TFF systems.

5. Documentation & Regulatory Support

  • Prepare and review protocols, technical reports, and regulatory documents (CTD sections).

  • Ensure accurate and compliant documentation in accordance with quality and regulatory standards.

6. Cross-Functional Collaboration

  • Work closely with IP, DPD, Regulatory, and Manufacturing teams to support product development and lifecycle management.

  • Contribute to non-infringing process development strategies in coordination with IP team.

7. Innovation & Capability Building

  • Evaluate and implement new technologies to enhance downstream processing efficiency and scalability.

  • Continuously improve departmental capabilities through training and process enhancement.

Qualification Required

PhD Biotechnology / MSc Biotechnology

Competencies

Intas - Action Oriented
Intas - Customer Focus
Intas - Dealing with Ambiguity
Intas - Problem Solving
Intas - Time Management

Relevant skills / Industry experience

10+ Years experience post PhD/15+ Years experience post Masters 
Location: 

Biotech, Ahmedabad, GJ, IN, 382213

Travel:  0% - 25%

Life at Intas Pharmaceuticals

For over three decades, Intas has thrived due to the exceptional talent of its people. Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success. We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape.
Date:  11 Apr 2025

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