Specialist Scientist DP Formulation – Large Molecule – Syngene, Bangalore

Job Description

Core Purpose of the Role:
Responsible for product & formulation development for large molecular parenteral drug products (protein, biosimilar, biological etc.) which includes formulation screening, FDS screening, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites.
Lead all activities for transferring lab process to GMP manufacturing site and facilitate drug product manufacturing in GMP fill finish facility, in coordination with production and quality team.
Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials

Qualifications

• Specific requirements for this role
• Experience in formulation development and technology transfer of large molecule parenteral drug products (protein, biosimilar, biological etc.)
• Demonstrated Capability:
• Experience in biologics formulation development, biosimilars, analytical characterization, technology transfer, and commercial manufacturing support.
• Strong exposure to global regulatory filings and commercialization of biosimilar and innovative biologics products.
• Experience working with CDMOs and global manufacturing networks will be highly desirable.
• Education: M Pharm Pharmaceutics / Master in Biotechnology
• Experience : 4+ Years

Skills Required

• Skills and Capabilities
• Must have significant experience in large molecule (biologics) drug product formulation and process development, supporting programs from preclinical and clinical development through commercialization.
• Demonstrated expertise in the development of biosimilars, recombinant proteins, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), fusion proteins, peptides, and novel biologics.
• Strong understanding of formulation strategies for biologics including: Excipient selection and optimization, Protein stabilization mechanisms, Aggregation control, Oxidation and deamidation mitigation, Freeze-thaw stability, Container closure compatibility
• Strong understanding of Protein manufacturing (upstreaming) and purification processes (down streaming) and established record for working closely with downstream team
• Extensive experience in reference product characterization, de-formulation, biosimilar analytical similarity assessment, and comparability studies to support biosimilar development programs.
• Hands-on experience in formulation development and scale-up of: Liquid formulations, Lyophilized formulations, High-concentration biologic formulations suitable for subcutaneous administration
• Expertise in the selection, characterization, and qualification of primary packaging systems including Vials, Prefilled syringes (PFS), Cartridges, Autoinjectors etc. along with associated regulatory expectations for US, EU, and global markets.
• Strong knowledge of protein analytical characterization techniques, including SEC-HPLC, CE-SDS, icIEF, IEX, HIC, RP-HPLC, ELISA, Binding assays, Bioassays, DLS, DSC, Particle characterization techniques.
• Thorough understanding of regulatory expectations for biosimilarity assessment, product comparability, and analytical similarity evaluations.
• Good understanding of process engineering principles and scale-dependent parameters required for successful transfer of biologics drug product manufacturing processes across development, pilot, and commercial scales.
• Hands-on experience in: Technology transfer activities, Process characterization, Process validation, Continued Process Verification (CPV), Process troubleshooting and root cause investigation.
• Expertise in development and optimization of Sterile filtration processes, Filter compatibility studies, Filter adsorption assessment, Filter validation studies for protein products
• Expertise in diafiltration, ultrafiltration, dialysis techniques with respect to large molecule
• Strong working knowledge of aseptic processing and manufacturing operations for biologics drug products.
• Expertise in design, development, optimization, and scale-up of lyophilization cycles for proteins, monoclonal antibodies, and other biologics, including characterization using thermal analytical techniques.
• Experience working in GMP-regulated environments with focus on: Data integrity, Compliance, Documentation practices, Health, safety, and environmental requirements
• Strong scientific skills for interpretation of analytical and process data, defining product critical quality attributes (CQAs), and making data-driven decisions.
• Experience authoring and reviewing technical reports, development reports, technology transfer documents, risk assessments, validation protocols, and regulatory supporting documentation.
• Work closely with Manufacturing, Quality Assurance, Quality Control, Validation, Regulatory Affairs, and Engineering teams, as well as external CDMOs/CMOs, to ensure successful process scale-up and site technology transfers.
• Good understanding of phase-appropriate GMP quality systems and clinical trial material supply requirements across different stages of development.
• Experience preparing, reviewing, and supporting GMP documentation.
• Working knowledge of quality management systems and deviation management, including’s investigations, OOT investigations, CAPA management, Change control, Risk assessments etc.
• Strong understanding of ICH, FDA, EMA, and global regulatory requirements related to biologics drug product development, technology transfer, process validation, and lifecycle management.
• Strong analytical thinking and risk assessment capabilities with proven ability to identify critical technical issues and implement effective mitigation strategies.
• Excellent communication, stakeholder management, and cross-functional leadership skills for driving complex development and technology transfer programs.
• Ability to effectively manage multiple projects, prioritize activities, and collaborate with functional and project management teams to achieve timelines, milestones, and business objectives.

Additional Information

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