Senior Scientist – Drug Product (DP) Formulation Development – Injectable
Location: Bangalore, Karnataka, India
Company: Syngene International
Department: Formulation Development
Employment Type: Full-Time
Role Summary
The Senior Scientist – DP Formulation Development is responsible for the development, optimization, characterization, scale-up, and technology transfer of injectable drug products across the product lifecycle. The role focuses on formulation development for both small molecules and biologics, including pre-formulation studies, process development, lyophilization, complex injectables, GMP manufacturing support, and commercialization activities.
This position works closely with manufacturing, quality, engineering, validation, regulatory affairs, and external manufacturing partners to ensure successful clinical and commercial supply of parenteral drug products while maintaining compliance with global regulatory standards.
Key Responsibilities
Formulation Development
Develop injectable drug product formulations from early-stage development through commercialization.
Conduct:
Pre-formulation Studies
Formulation Design
Formulation Optimization
Process Characterization
Comparability Studies
Support both:
Small Molecule Injectables
Large Molecule/Biologics Products
Technology Transfer
Lead technology transfer activities from R&D to GMP manufacturing facilities.
Coordinate with:
Manufacturing Teams
Quality Teams
Engineering Teams
Validation Teams
External CMOs/CDMOs
Ensure successful scale-up and process transfer.
Process Development & Optimization
Optimize manufacturing processes using a Right-First-Time approach.
Support clinical and commercial drug product manufacturing.
Troubleshoot manufacturing and process-related challenges.
Conduct process validation activities.
Complex Injectable Development
Develop and characterize:
Liposomes
Nanoemulsions
Nanoparticles
Microspheres
Polymer Conjugates
Complex Injectable Systems
Perform reference product characterization and de-formulation studies.
Packaging & Device Development
Lead packaging and delivery system selection for:
Vials
Pre-Filled Syringes (PFS)
Autoinjectors
Ensure compliance with:
US FDA Requirements
European Regulatory Requirements
Lyophilization Development
Design and optimize lyophilization cycles.
Support freeze-dried formulations for biologics and injectable products.
Evaluate process performance and stability.
Analytical & Characterization Support
Utilize analytical characterization techniques for:
Purity Assessment
Potency Assessment
Similarity Assessment
Biosimilar Comparability
Interpret scientific data and generate technical conclusions.
Filtration & Sterile Processing
Perform:
Filter Selection
Filter Optimization
Filter Validation Studies
Support sterile manufacturing processes and containment strategies.
GMP Manufacturing Support
Facilitate drug product manufacturing in GMP fill-finish facilities.
Ensure:
Data Integrity
GMP Compliance
Safety Compliance
Support batch execution and process monitoring.
Quality Systems & Compliance
Manage:
Deviations
OOS (Out of Specification)
OOT (Out of Trend)
CAPA Investigations
Change Controls
Ensure compliance with:
GxP Requirements
GMP Standards
Internal SOPs
Documentation & Regulatory Support
Prepare and review:
MFR (Master Formula Records)
MPR (Master Production Records)
BMR (Batch Manufacturing Records)
BPR (Batch Packaging Records)
PPQP
PPQR
Support regulatory submissions for:
US FDA
EMA
ROW Markets
Cross-Functional Collaboration
Collaborate with:
Manufacturing
Engineering
Validation
Quality Assurance
Regulatory Affairs
Project Management
Manage project milestones and timelines.
Support client and regulatory audits.
Required Qualifications
Education
M.Pharm / MS / M.Tech / PhD in:
Pharmaceutics
Pharmaceutical Technology
Biotechnology
Chemical Engineering
Pharmaceutical Sciences
Life Sciences
Related Discipline
Experience
Required Experience
Typically 8–15+ Years in:
Injectable Formulation Development
Drug Product Development
Technology Transfer
GMP Manufacturing Support
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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