Rubicon Research Limited
Website:
rubicon.co.in
Company:
https://www.linkedin.com/company/rubiconresearch
Industries: Pharmaceutical Manufacturing
Job details:
This role will be responsible for the formulation development and optimization of oral solid and liquid dosage forms for the US market, ensuring successful product development from concept through technology transfer in compliance with regulatory and quality requirements.
Position / Job Title - AGM
Department - Formulation Development
Reporting To - Vice President
Location - Thane
Years of Experience - 15 to 20 years
Dosage Form - Solid and Liquid Orals
Job Responsibilities / Deliverables -
To understand project scope, define the activities and timelines and to 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 the 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 -
Minimum master’s degree in Pharmaceutical Sciences educational background with 15 to 20 years relevant experience.
Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry.
Strong understanding of the product development process from concept ideation to launch.
Additional notes
Role is expected to work in any of the shifts based on the requirement.
Expected to visit external manufacturing sites whenever required.
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