Assist in execution ofgeneric and NDA formulation developmentof sterile ophthalmic and non-sterile dermatological products for regulated and non-regulated markets.
Conduct literature search, patent evaluation and preparation of literature report.
Preparation of documents such as formulation development approach paper,stability protocol and report, drug-excipient study protocol and report, bill of material, master formula card, batch manufacturing record, physical method development protocol and report, SOP, format, CoA, etc.
Perform pre-formulation studies including API and innovator product characterization, etc.
Procurement of API, raw material and packaging material for development batches.
Manufacturing of lab scale batches and evaluation of in-process, finished product and stability samples.
Preparation of stability sample withdrawal schedule and updating of stability grid.
Stability sample charging and withdrawal as per stability scheduler.
Assist and/or execute formula and process optimization studies.
Assist in execution of technology transfer and scale-up, pilot, trial/engineering, exhibit/registration batchesand validation activities at plant.
Issuance, maintenance, writingof raw dataand archival of laboratory notebook.
Routine calibration and qualification of laboratory instruments and equipment.
To prepare and maintain hard copy binder for Material Safety Data Sheet (MSDS) of API and excipients used in formulation development of various projects.
Follow strict adherence to Good Documentation Practices and Good Laboratory Practices.
Maintain document files, stability protocol, record of logbook issuance, checking and archival.
Co-ordinate and interact with Analytical Development, QA, Purchase, Procurement, Regulatory Affairs, Production, QC, etc. for smooth execution of various projects.
Maintenance of Formulation lab functionality as per requirement.
Must have goodcommunication, writing and inter-personal skills.
Effective planning, quality execution and organization of work is a must.
Any other duties as per organizational requirements.
Employement Category:
Employement Type: Internship Industry: Pharma / Biotech Role Category: Bio Tech / R&D / Scientist Functional Area: Not Applicable Role/Responsibilies: Formulation Trainee
Contact Details:
Company: Galentic Pharma India Location(s): Mumbai