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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Management Consulting / Strategy |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site.
Core Job Responsibilities Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. Use of QbD wherever required for Product and process optimization. Ensure proper upkeep, maintenance and calibration of the equipment. Ensure scale up of the developed formulation works at engineering batch level. Development of the patent non-infringing strategy for product development. Preparation of regulatory documents for PK study and marketing approval from DCG (I). Preparation of Pharmaceutical Development report for Quality module of CTD.
Key Deliverables:
Literature/Patent search to create drug profile Prototype development with rationale use of excipients Pre-formulation study as may be required for formulation development Conduct 6 months accelerated stability studies to ensure stable formulation Proof of concept studies to demonstrate BE or comparative PK as the case may be Scale up studies at 1/10th scale or engineering batch Technology transfer and manufacturing of Bio/Clinical batch
Critical Success Factors:
Functional/ Technical:
Formulation and Product Development Schedule and follow all the steps to deliver the drug as per QTPP Select the suitable polymers / excipients based on either properties or scientific rationale Evaluation of CQA of drug / excipients and estimate its implications for product development Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly Plan and executes the trial to identify Critical Process Parameters (CPP) and design the control strategy Overcomes the limitations / problems and effectively resolves the same
Design of Experiments Plans and executes the experiments as per DOE to optimize product and process Applies basic principles of experimentation Pharmaceutical Development Report (PDR) Prepares PDR as per Common Technical Document (CTD) module 3 requirements Complies with regulatory requirements as defined in QTPP Project Management Is able to plan and prioritise multiple project deadlines to meet product delivery goals
Desired Candidate : Education experience:
M. Pharm/Ph. D. 5 - 10 yrs experience into Formulation Development Should have experience into Liquid Oral Dosage form.
,Keyskills :
research hplc chemistry validation api proofofconcept designofexperiments commontechnicaldocument continuousimprovementfacilitation costeffective stabilitystudies projectmanagement productdevelopment technologytransfer formulationdevelopment