Website www.twitter.com/drgjpmc DRG Job Placement Manpower Consultant Hyderabad
Position:Formulation and Development Specialist (Parenteral, Injectable and Ophthalmic)
Location: Pragathi Nagar, Hyderabad, Telangana 500090
Exp: 5- 7 years
Salary: 4- 6LPA
Qualification: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
Roles and Responsibilities
Responsible for the development of new products and optimization of existing formulas; product lines including traditional solid dosage products (tablets, capsules) and other delivery forms (e.g. liquids, powders).
Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshoot and problem-solve unresolved or new formula issues.
Design and execute formulation trials and evaluate stability data to finalize formulation composition.
Develop robust manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
Support the manufacturing of exhibit/submission batches per regulatory requirements.
Support technology transfer for manufacturing processes from laboratory scale to production scale.
Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs.
Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.
Qualifications & Pre–Requisites
Masters Degree in Pharmaceutical sciences educational background with 1-3 years of experience in related field.
Knowledge of regulatory guidances
Exposure of pellet projects and liquid oral projects will be an added advantage for the role.