Job Description
Purpose
Responsible for the development of new products and optimization of existing formulations; product lines including Solid and Liquid Dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS etc.) for regulated markets like US, Europe and ROW. Perform duties in accordance with Rubicon policies and procedures.
Position / Job Title
Senior executive
Department
Formulation Development
Reporting To
Senior Manager
Location
Thane
Years Of Experience
5 + years
Dosage Form
Solid & Liquid Oral, Pellets, MUPS
Job Responsibilities / Deliverables
Responsible for formulation and process development of oral dosage forms (Solid & Liquid Oral, Pellets, MUPS). Troubleshooting and problem-solving of unresolved or new formula issues.
Design and execute formulation trials and evaluate stability data to finalize formulation composition.
Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
Support the manufacturing of exhibit/submission batches per regulatory requirements.
Support technology transfer for manufacturing processes from laboratory scale to production scale.
Guide to junior team members for routine activities.
Works with Analytical 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 cGMPs.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc.
To understand project scope, define the activities and timelines and ensure periodic monitoring and timely completion of the same.
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 and 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.
