Manager – Biotechnology (Downstream Processing)
R&D – Regulatory Affairs (Biologics)
Location: Tandalja
Company: Sun Pharmaceutical Industries Ltd
Business Unit: R&D1 – Regulatory Affairs / Biological Drug Substance Unit
Job Grade: G11A
Company Overview
Sun Pharmaceutical Industries Ltd is a global pharmaceutical organization with strong capabilities in both generics and biologics development.
Key Highlights
Global presence in multiple regulated markets
Strong R&D and biologics pipeline
Focus on:
Monoclonal antibodies (mAbs)
Recombinant proteins
Complex biologics and biosimilars
Integrated capabilities across development, manufacturing, and regulatory functions
Job Objective
The role leads the downstream processing group within the Biological Drug Substance Unit, ensuring efficient development and scale-up of purification processes for recombinant proteins and monoclonal antibodies.
Key focus areas:
Process development and optimization
Scale-up and GMP production support
On-time delivery of clinical batches
Cost and timeline adherence
Scientific leadership in downstream processing
Key Responsibilities
1. Downstream Process Development Leadership
Lead downstream processing group for biologics development
Design, plan, operate, and monitor downstream activities
Support both:
Process development activities
Scale-up and GMP manufacturing operations
2. Biologics Purification Expertise
Develop and optimize purification processes for:
Recombinant proteins
Monoclonal antibodies (mAbs)
Ensure robustness and scalability of processes
3. Chromatography & Filtration Systems
Operate and manage:
Chromatographic systems
Tangential Flow Filtration (TFF) systems
Filtration systems
Interpret experimental and process data using standard analytical tools
4. Scale-Up & Process Engineering
Apply downstream scale-up principles
Ensure smooth transition from lab scale to manufacturing scale
Support process consistency across development and GMP production
5. Data Interpretation & Documentation
Analyze and interpret:
Analytical data
Process performance data
Prepare technical documents including:
Batch Manufacturing Records (BMR)
Standard Operating Procedures (SOPs)
Investigation protocols
Technical reports
6. GMP & Compliance Support
Ensure compliance with GMP requirements during downstream operations
Support documentation and regulatory readiness for clinical batches
7. Mentorship & Team Development
Mentor junior scientists and associates
Provide technical guidance in:
Downstream processing
Bioprocess optimization
Support capability building within the team
Technical Expertise Required
Bioprocess Engineering
Downstream biologics processing
Protein purification workflows
Process development and scale-up
Core Technologies
Chromatography systems (e.g., affinity, ion exchange, size exclusion)
TFF (Tangential Flow Filtration) systems
Filtration technologies
Analytical & Process Skills
Data interpretation and process optimization
Analytical method understanding for biologics
Process performance evaluation
Documentation & Compliance
SOP writing
BMR preparation
Investigation reports
GMP documentation practices
Educational Qualification
M.Sc. or M.Tech in:
Biochemistry
Biotechnology
Life Sciences
Experience Requirements
9–12 years of experience in biotechnology / biopharmaceutical R&D
Strong background in downstream processing of biologics
Experience in:
Recombinant proteins
Monoclonal antibodies
GMP or clinical-scale biologics manufacturing support
Behavioral Competencies
Strong scientific leadership ability
Mentorship and team development mindset
Analytical and problem-solving skills
Strong ownership and accountability
Ability to work in cross-functional environments
Attention to detail with process orientation
Strong communication and documentation skills
Work Culture
Sun Pharmaceutical Industries Ltd promotes:
Continuous learning and scientific growth
Ownership-driven leadership (“Take charge”)
Collaboration across R&D and manufacturing teams (“Thrive together”)
Innovation in biologics and advanced therapies
Performance-driven research environment
Role Summary (In Simple Terms)
This is a senior biotech R&D role focused on:
Purifying biologic drugs (proteins & antibodies)
Scaling processes from lab to production
Leading a technical downstream processing team
Ensuring GMP-compliant clinical batch delivery
Mentoring junior scientists in biologics development
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