Formulation Development Lead
4 weeks ago
Purpose
Responsible for the development of new products and optimization of existing formulations;
product lines includingSolid and Liquid Dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS etc.) for regulated markets like US, Europe and ROW.
Location:
Thane, Maharashtra
Job Responsibilities / Deliverables
- To understand project scope, define the activities and timelines and ensure periodic monitoring and timely completion of the same.
- To lead on the execution/development of new formulations by investigating characteristics of API and its viability, safety and compatibility with other ingredients, defining the material characteristics, performing required testing, and conducting scale up studies.
- To identify the resource requirement for the projects such as materials, manpower, machine change parts as well as to assimilate all the literature information collected by project teams and ensure appropriate usage throughout development.
- Develop R&D plans and experimental designs by applying QBD principles for all new product development projects and processes: Analyze data to provide a relevant interpretation, draw valid conclusions and make appropriate recommendations for further advancement in product development.
- To effectively plan & coordinate execution of lab scale up/ optimization and pilot BE batches by ensuring strict adherence to lab GMP system and practices.
- Timely review of Lab experiment notebooks as well as preparation and review of technology transfer documents
- To liaison and coordinate with technology transfer team / production team of respective manufacturing site to ensure seamless technology transfer by executing plant scale-up and exhibit batches as well as to review batch manufacturing and process validation documents.
- Program for the optimization of existing product performance by investigating API characteristics and finished products, researching viability, safety and compatibility of ingredients and formulas.
- Check stability protocols, monitor stability studies and evaluate/interpret the results to advance further for product development activity accordingly.
- To liaison and communicate with various other departments such as project management, analytical development, supply chain team, clinical, regulatory and IP department as per the required product development activity to ensure timely completion of the project.
- To prepare new departmental SOPs, manuals and guidelines documents as on when required as well as to renew existing SOPs, manuals and guidelines documents.
- To monitor IQ, OQ and PQ activities of new machines and to ensure proper functioning & maintenance of all equipment & instruments including necessary.
- To ensure proper training of the subordinates, technicians and housekeeping personnel on various equipment, instruments and systems in the department.
- To ensure proper storage & destruction of raw materials & finished goods and to maintain up to date RLD samples inventory.
- To participate in the departmental Audits and ensure compliance to the recommendations.
- To read and update oneself/ team with the latest developments w.R.T. technology, conceptual thinking, presentation and communication skills.
Qualifications & Pre-Requisites
- Master in pharmacy (Pharmaceutics)
- Must-Have Skills: Formulation development experience of Solid & Liquid Oral, application of QBD principle preferred to have Pellets project experience.
Additional notes
- Role is expected to work in extended hours/any of the shift based on the requirement.
- Expected to visit manufacturing sites, whenever required.
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