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

Job content

Roles and Responsibilities

Candidate should have gained experience in end-to-end product development/ process development of Injectable/ Parenteral dosage forms including complex injectables.

• Already leading a Parenteral Group/ Generic Pharmaceutical Injectable Development group and can independently handle the Parenteral group and accountable to all Injectable product related queries by different regulatory agencies and management.
• Having experience of Pharmaceutical Injectable Lab/ USFDA approved GMP Plant set-up is preferred.
• Having experience of Budgeting of Injectable lab/ GMP Plant and Product development cost from start to end is required.
• Candidate must have experience for Injectable formulation equipment / instruments installation, operation & performance qualification.
• Responsible for preparation and review of SOPs, protocols, reports, policies etc of Injectable Formulation Development (FD) dept.
• Supporting formulation development laboratory for maintaining high standards of safety.
• Responsibility of Lab in charge for Injectable formulation laboratory for maintaining high standards of safety.
• Maintaining parenteral department for real time ready situation for internal as well external audits.
• Planning and monitoring of injectable projects from project feasibility stage to commercial for regulated and ROW market.
• Responsible for enhancing productivity and team building.
• Mentoring scientists for injectable product development of complex generic injectable products exclusively for parenteral dosage forms.
• Must have sufficient exposure in Complex Injectable product development to Scale-up to Exhibit & Commercial Batch manufacturing.
• Having experience of 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 injectable formulation activity from project feasibility stage to commercial.
• Display good understanding of physical & chemical properties of materials used in injectable formulations and applications to own area through relevant pre-formulation studies.
• Having good experience in Reverse Engineering of Innovators product.
• Demonstrates understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ injectable products
• To Guide for preformulating trials & development batches during development of Parenteral products.
• 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 injectable 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 injectable products.
• Identify the training needs of the team and implement effective training calendar for all the team members.
• Vast experience of Injectable generic product development and troubleshooting for regulated market is preferred.
• Good communication and Coordination skills and ability to work with a diverse cross-functional teams.
• Good analytical data interpretation skills and report writing skill with creative thinking ability.

Desired Candidate Profile

Candidate with experience in Pharmaceutical company, Pharmaceutical R&D, Pharmaceutical Contract Research Organization (CRO).

Candidates having experience in USFDA approved Pharmaceutical company, WHO GMP approved pharmaceutical company, Pharmaceutical CRO will be preferred.

Perks and Benefits

As per Industry Norms