Pr. Scientist/ GL ( Formulation Development- OSD Formulation) R&D

工作内容

Roles and Responsibilities

Candidate should have gained experience in end-to-end product development/ process development of Oral Solid dosage forms and including complex generic and niche OSD products.

• Already having leadership experience of handling a group of analytical scientists in a Analytical dept. for Generic Pharmaceutical product development and can independently handle the Analytical team and accountable to all analytical related queries by different regulatory agencies and management.
• Having prior experience and involvement in Formulation Lab set-up activities.
• Candidate must have experience for formulation equipment / instruments installation, operation & performance qualification.
• Responsible for preparation and review of SOPs, protocols, reports, policies etc of Formulation Development (FD) dept.
• Supporting formulation development laboratory for maintaining high standards of safety.
• Having experience of mentoring and handling of FD team members and good inter-departmental communications are required.
• Maintaining formulation department for real time ready situation for internal as well external audits.
• Planning, execution and monitoring of projects of formulation activity from project feasibility stage to commercial.
• Display good understanding of physical & chemical properties of materials used in formulations and applications to own area through relevant pre-formulation studies.
• Having good experience in Reverse Engineering of Innovator’s product.
• Demonstrates understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ products
• Planning, monitoring and execution of projects for OSD formulation development activity from project feasibility stage to commercial.
• Mentoring scientists for QbD based formulation development of complex generic products exclusively for oral solid dosage forms and parenteral product as an added advantage.
• Coordination with analytical department for various analytical activities.
• Coordination with External parent company’s Formulation, Analytical, RA and PM team as per project requirement for all required project activities.
• To do proper documentation and submit samples to concerned department on time for test.
• Design the scheme of experiments. Interpret the results from various analytical instruments like HPLC, UV, GC, IR, etc.
• Visualize the developmental needs of the product.
• Perform experiments for establishing the compatibility between API and excipients.
• Carry out stability at each stage of formulations development.
• Submit samples for conducting pilot and pivotal Bio studies on the PE batch and Exhibit batches respectively in consultation with Biopharmaceutics Team.
• Understand the safety and environmental aspect.
• Solve the problems and queries related to the development of the formulation and discuss them with the Tech Lead.
• Understand/familiarize with the problems faced during Scale-up.
• Understand the scalability of the chosen process.
• Having experience of successful technology transfer from R&D to Plant scale.
• Analyze the formulation strategy, efficiency, working relations and cross-functional issues in R&D.
• Calibrate the instruments/ equipment’s, if required according to the master calibration schedule and follow the SOPs.
• Keep the work area clean and the laboratory under controlled temperature.
• Co-ordination with analytical team and providing product development and sample submission planning support as per the project requirement. Review and analysis of results and discussion with the analytical team during the product development.
• Interaction with inter department for regulatory filing documentation requirements.
• Respond to regulatory deficiencies on time for respective products.
• Understanding regulatory queries, providing scientific justifications and responding to regulatory queries as and when required on time for respective products.
• Review of regulatory submission documents for adequacy.
• Identify the training needs of the team and implement effective training calendar for all the team members.
• Experience of generic product development and troubleshooting for regulated market is preferred.
• Good communication and Coordination skills and ability to work with diverse cross-functional teams.
• Good analytical data interpretation skills and report writing skill with creative thinking ability.

Desired Candidate Profile

PG: M Pharm

PhD

Perks and Benefits

As per Industry Norms.