Expected Experience : 6 to 10 years preferably in Injectable / Ophthalmic development for regulated markets.
No.of Position : 1
Job Location : Navi Mumbai

Responsibilities:

Direct and manage a team of scientists for the planning and execution of product development activity for ROW/ANDA projects of Parenteral / Ophthalmic dosage forms. Dosage forms like Lyophilized, Liquid Injections in Ampoules, vials, PFS, Emulsions and suspensions, Ophthalmic formulations & Novel Drug Delivery Systems (NDDS).

Plan detailed activities related to formulation development in line with QbD concepts and execution shall be done within targeted time limits.

To review product literature and patent for Quantitative and Qualitative Pre- formulation studies of New Products as per Regulatory requirements.

Formulation designing, Process optimization studies during development and support Scaleup as well as Transfer of Technology from F&D Department to Manufacturing unit.

Understand / familiarize with the problems faced during Scale-up & Overseeing implementation of Critical Process Parameters (CPP) for Validation / Commercials at plant.

Plan, perform and contribute to project related scientific / technical activities (e.g., interpretation of results, data evaluation, draw relevant conclusions and write reports).

To check pharmaceutical development reports for the same and to give inputs for regulatory filings.

To coordinate with various cross functional teams for timely meeting the F&D projects completion schedules.

To check departmental SOPs, MFRs, Protocols and Reports related to the product.

To guide or mentor the teammates with valuable inputs and recent developments in the pharma field.

Expected Experience : 4 to 6 yrs
No.of Position : 2
Job Location : Goregaon & Navi Mumbai

Responsibilities:

Communicating Stakeholders regarding new Project introduction.

Planning, scheduling and monitoring all the Projects.

Coordinate with concerned team for Test License/Import License.

Conducting regular meetings for reviewing updated status of ongoing Projects and resolving issues.

Coordination with Technical Services, Purchase, Commercial, Warehouse, QC and QA for availability and release of RM, PM and API, RLD/RS Products.

Coordination with Production Planning, for Slot availability at Plant Facility.

Travelling to plant if required.

Coordination with CFTs for executing Optimization, Scale-up and Validation batches.

Getting Stakeholders delegated from Cross functional Departments post receipt of Vendor Docket from Commercial.

Timely escalation of critical issues to respective Stakeholders/Management to avoid delays. Mitigating risks and communicating the same to Stakeholders. Controlling the Projects with respect to committed time lines for completion of each Task. Resolving conflicts between Stakeholders related to Projects.

Arranging required Data, Samples of API and Finish Product from Plant Facility. Arranging CFT Meetings post completion of Milestone activity for closely planning and scheduling upcoming tasks.

Expected Experience : 2 to 4 yrs
No.of Position : 3
Job Location : Navi Mumbai

Responsibilities:

Responsible for Initiation to Completion of all the activities for assigned projects.

Planning and Execution of Experiments.

Develop robust formulations and processes for general products to Non-Regulatory. Regulatory market with application on QBD as needed.

Preparation of Development and Equipment related SOP'S for new FND lab.

Literature Review (Patent database).

Pre-formulation study for API and Excipients for development.

Procurement of Raw materials/ Excipients for project.

Participate in conducting stability studies for various formulation as per ICH guildelines and taking stability batches follow up.

Can work with team or single on any type of project assigned and supporting the formulation team for completion of allocated project within the time lines by trouble shooting the concerns involved.

Work proactively with other cross-functional groups to execute all products related such as Manufacturing and packaging Master records. SOP'S and Protocols etc.

Expected Experience : 2 to 4 yrs
No.of Position : 3
Job Location : Navi Mumbai

Responsibilities:

To maintain the Quality results ,regulatory compliance & improvement of existing system to eliminate the possibility of occurrence of non conformance.

Operation, Calibration and maintenance of various instruments like HPLC, Dissolution, Analytical Balance, UV spectro photometer, Viscometer, GC etc.

To maintain and record online entry into usage log book of instruments.

To follow good laboratory and good documentation practices.

To Peform analysis as mentioned in Test request form following correct test procedure like analytical validations/verification, routine analysis and stability studies etc.

Basic knowledge of Method development and Validation.