USV Pvt Ltd Looking for Senior Officer / Executive – Formulation Development at Mumbai Full Time

Job Description

Formulation development:

• Prepare documentation for filing of various licenses (API/innovator import, FDA, etc.)
• Assist the group leader in conducting literature review by collating relevant documents and developing design input
• Conduct, observe and document lab-experiments related to Innovator profiling, Packaging evaluation, API/excipient/capsule evaluation, product formulation (composition and process) and specifications. Provide qualified inputs to the process by leveraging technical expertise.
• Conduct, observe and document lab work across various stages (excipient compatibility, feasibility experiments, stability, reproducibility, pilot BE , DoE, optimization and scale-up)
• Maintain logs of all lab activity/ experiments in lab notebook on a regular basis
• Provide samples to ARL for testing at all stages of the process. Collect, compile, review, discuss and file the reports of analysis
• Send the properly labelled samples to clinical department along with the documents
• Prepare PDR and QOS by capturing relevant inputs from various lab experiments
• Provide checklist to the TT team for the documentation for the plant batches

Plant Transfer:

• Respond to queries raised by plant during production; while being present to witness production of Scale-up, assessment, Regulatory submission and Commercial validation batches
• Participate in pivotal bio study by sending samples (containers) to CRO (via clinical)
• Provide qualified inputs (stability protocol and training documents) to QRM creation
• Conduct comparative studies (all previous lab batches with plant batches) to check parameters
• Prepare and execute Tech Transfer Documents (TTD) and submit to SCM/ QA/Plant
• Plan and coordinate (along with Mfg site) for manufacture of assessment batch/es and preparation of Scale-up reports.
• Plan and coordinate (along with Mfg Site) for manufacture of first 3 commercial batches for domestic projects at in-house/TP/LL facilities.
• Stability follow-up of assessment and commercial batches, compilation and analysis of data.

Regulatory and compliance

• Adhere to regulatory, cGMP, SOPs and safety guidelines for all processes
• Ensure timely closure of regulatory queries by conducting and documenting specified experiments in the lab
• Ensure data integrity in all respects

Stores, tools and material management

• Calculate required quantities of reference innovator product for order placement (on-going)
• Provide inputs for placing orders for tooling equipment
• Provide input for the procurement of API and the excipients, packaging material and the accessories
• Ensure regular calibration of balances and equipment in the lab as per schedule