DP MSAT Associate-Hyderabad
- Responsible for Product transfer / new product introduction, Technology Absorption, Process qualification activities for Biological products/ Injectable products
- Monitoring, support and execution of trial, scale up, manufacturing of clinical batches & Process validation batches and site to site transfer of biological products and new products from R&D to manufacturing plant.
- Knowledge in Aseptic manufacturing operations of fill finish facility (liquid & lyo injectables)
- Initiation, Review and Approval of change controls, Incidents and risk assessment with respect to transfer of biological products and new products from R&D to manufacturing plant.
- Able to design, execute and conclude on the mixing / homogeneity studies.
- Preparation and approval of material reservation in System Application and products (i.e. SAP).
- Process / Product Risk assessment and evaluation, recommendation on proposed changes.
- Responsible for Execution and participation of Pre-validation / Process performance qualification batches and Continued process verification, Process simplification, machine change, batch size change and other routine Validation / Qualifications.
- Responsible to perform/review the investigations arising from incidents, out of specifications, out of trends, product failures, to identify the root cause and implement appropriate corrective and preventive actions.
- Co-ordination with Production, Quality Assurance, Regulatory Affair, Quality Control, Supply Chain Management & vendors for collection of data /reports.
- Preparation, Review and approval of following documents but not limited too,
- Trial batches/ Phase-I/Phase III/ Pre-validation/ Process performance qualification batches Protocols & Reports.
- Master Formula Record, Batch Manufacturing records, BOM for Raw Material, Packing Material,
- Equivalency Report, Technical and scale up evaluation Reports, Hold time Study Protocol and Reports.
- Filter validation studies
- Exposure to global regulatory filings (Ex: USFDA and EU) and has been part of CMC review is an advantage.
Educational qualification: B.Tech, B. Pharm Master’s (M.Tech. or M.Sc in life sciences or pharmaceutical sciences or M.Pharm) or a Ph.D.
Minimum work experience:
Minimum 10-15 yrs. of experience in the product manufacturing, development and tech transfer activities for biological molecules/ injectable products, knowledge of Aseptic manufacturing & filling operations.
Skills & attributes:
Technical Skills
• Thorough knowledge of Biologic formulation and filling processes.
• Knowledge in Aseptic manufacturing operations of fill finish facility (liquid & lyo injectables)
• Proficiency in scaling up manufacturing processes from laboratory-scale to larger production scales and transferring technology between different manufacturing sites at a clinical or commercial facility.
• Experience and understanding of Continued Process Verification.
• Familiarity and proficiency in using statistical software, particularly JMP, for data analysis, interpretation, and decision-making in the context of process optimization and control.
• Expertise in authoring documents related to cGMP and developmental processes, including process validation protocols and reports.
• Ability to identify, analyse, and resolve issues or challenges that may arise during the manufacturing process, ensuring continuous improvement.
• Skills in conducting risk assessments and comprehensive understanding and application of Quality Management Systems.
• Expertise in designing, optimizing, and implementing formulation, filling and assembly processes in a manufacturing environment.
Behavioural skills
• Ability to convey complex injectable processes and technical information clearly to diverse audiences, including team members, management, and cross-functional teams.
• Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
• Strong analytical and problem-solving skills to address challenges.
• Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.
• Takes responsibility and maintains a disciplined and agile approach to execution.
