Formulation development of solid dosage forms for ROW markets (Europe, Brazil, Canada, South Africa, Australia and Asian)
Dossier extension initiation activities (loading, review and circulation of dossier extension information to all stake holders and approval of the same).
A thorough due diligence of base market (US or Europe) dossier, identifying gaps against intended regulatory market requirements and generation of documentation accordingly.
RM indenting, RM and finished good specs generation, trade dress approval and participation in execution of submission batches for dossier extension markets.
Hands on experience on software tools (SAP, DoE, Docs control systems and etc.,) for online loading/review/approval of docs.
Preparation of product development report by necessary modification of existing base market development report.
Design and conduct of experiments leading to pre-formulation, formulation development and scale up of the formulation with an objective to develop a product suitable for intended market. Carry out necessary activities for the scale up and technology transfer of the product to manufacturing location for registration of dossiers and validations of the process. Preparation and review of documents as per the requirements of the product development and technology transfer activities. Coordinate with cross functional departments to fulfil the project objectives.
Managing group of team members by regular interaction and arranging cross functional team meetings and coordination with plant for execution of scale up/EB
Coordination with BD for trade dress approval.
Coordination with IPR for formulation strategy clearance.
Coordination with sourcing team for identifying and qualification of new source.
Coordination with ADL for method development, method transfer & validation activities.
Coordination with Packaging team for identifying suitable packs & pack strategy.
Formulation development of oral solid dosage forms experience. Good understanding on regulatory requirement of EU, Canada, Australia, SA, Brazil and other markets apart from US. Scale up & tech transfer experience will be value added.
Formulation development of solid dosage forms for Europe market and extension of same to Canada, Australia, South Africa, Brazil etc., Making strategy for formulation development keeping in mind the targets for delivery. Design and conduct of experiments leading to pre-formulation, formulation development and scale up of the formulation with an objective to develop a product suitable for intended market. Carry out necessary activities for the scale up and technology transfer of the product to manufacturing location for registration of dossiers and validations of the process. Preparation and review of documents as per the requirements of the product development and technology transfer activities. Coordinate with cross functional departments to fulfil the project objectives.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Formulation Development Method Development Technology Transfer Product Development Tech Transfer Method Transfer South Africa
Desired Candidate Profile:
Please refer to the Job description above
UG: B.Sc – Any Specialization, B.Pharma – Pharmacy
PG:MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy
Doctorate:Doctorate Not Required
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, with an established presence in the Indian pharma industry has a proud, historical track record going back one hundred years. With a turnover in excess of Rs. 1200 crores today, Alembic Limited is one of India’s leading integrated pharmaceutical companies. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough and also have significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc. We have also plans for expansion in Ophthalmic etc. Alembic’s manufacturing facilities are at Vadodara, Panelav in Gujarat, and Baddi in Himachal Pradesh. The facilities are approved by the US FDA, EDQM, TGA, MHRA, and MCC. Alembic Research Center (ARC) a world-class research organization provides a comprehensive range of services in the areas of synthetic chemistry, formulations, NDDS, as also preclinical pharmacology, bioequivalence / bioanalytical studies, etc. ARC, designed to state-of-the-art GLP standards, is spread over an area of 120,000 sq ft, manned by over 300 scientists working on latest technology and systems. Our current employee strength is in excess of 4500 across the country. A continuously expanding organization, we invite dynamic, result-oriented professionals to join us across various functions.
Recruiter Name:Mrs. Arti Panchal (Sikligar)
Address:3rd Floor, Human Resources, Alembic RoadVADODARA,Gujarat,India 390003