Formulation And Development

TEAM LEADER - FORMULATION AND DEVELOPMENT INJECTABLE

Activities and Responsibilities :-

• Coordinate with formulation scientists for day-to-day activities, designing formulation strategies, execution of laboratory trials and preparation of technical documents for sterile dosage forms.
• Coordinate with other technical staff responsible for testing new drug substances, excipients, pre-formulation samples, and formulation development samples. Ensure the timely completion of new product development of sterile dosage form.
• Interact with Manufacturing, Validation, and Materials Management teams to ensure smooth drug product development and transition to commercial-scale manufacturing. Manage all activities associated with registration batch manufacturing, including authoring, reviewing, and approving technical documents.
• To perform, review and interpret literature related to drug products, including patents, research articles, reference product details, drug substance information, and excipient details.
• Provide support in troubleshooting formulation and process-related issues for both sterile and sterile dosage forms.
• To perform various studies such as pre-formulation studies, API characterization study, excipient characterization study, excipient optimization studies, filter compatibility studies, tubing compatibility studies, bulk hold in SS vessels / SS compatibility studies, pH optimization studies, nitrogen requirement studies, photo stability studies, freeze-thaw studies, in-use studies, dilution compatibility studies, selection of sterilization methods, selection of packaging materials, stress studies, and scale-up operations.
• To perform all required activities, i.e., procurement of raw materials, packaging materials, and processing aids etc. for the initiation and execution of development batches, process validation/ exhibit batches and commercial batches of the drug product.
• To prepare and review product-specific risk assessments, QQ, Master Formulation Records (MFR), development batch Stability Protocols, Scale-up BMRs, Scale-up reports, Product Development Reports (PDR), etc.
• To propose and review finished product specifications to the Analytical Development Laboratory (ADL) based on dosage form requirements.
• To prepare and review of technical documents based on CTD required for dossier submission and handling all technical queries raised by all respected regulatory authority. Percolate the instruction and work assigned by Head R & D to Team members for timely completion of activities.
• To prepare and review Standard Operating Procedures (SOPs) and related documents, ensuring work is performed according to SOPs, Good Manufacturing Practices (GMP), and safety guidelines in the R&D department.
• To assist and support in the preparation and review of qualification and validation documents, change controls, deviations, investigations, and CAPAs.
• To visit LL sites and third-party sites for development batch trials or batch execution as required.
• To be responsible for coordination, execution, monitoring, and troubleshooting of scale-up batches, exhibit batches, process validation batches, and commercial batches at in-house manufacturing sites, CMO sites, TT sites, and LL sites.
• To co-ordination with Cross Functional Team to ensure timely completion of assigned activities.
• To perform any other task assigned by HOD / Management.

THANKS YOU

REGARDS

MILAP RATHOD

HR DEPARTMENT

OPES HEALTHCARE PRIVATE LIMITED