Senior Manager (Team Leader)
Current505B2 Formulation research and development for the US market involving solutions and suspension dosage forms.• Contribute to new product ideation by evaluating the technical feasibility, clinical pathway, regulatory pathway and facility requirements for the program.• Manage and provide technical leadership to the junior formulation scientists working with the team.• Lay down program timelines and budget for approval from ELT. Help track the program expenses with the help of finance and project management team.• Coordinate program initiation by arranging licenses, equipment, new product introduction form, instrument, and license requirements.• Lay down experimental strategy in consultation with delivery captain, execute the plan with the help of team members and update the relevant stakeholder on the conclusions and way forward. Support for provision and patent filing.• Coordinate with clinical team for getting the required documentation and licenses in lace.• Coordinate with PM and CRO for execution of clinical studies as per the program timelines.• Follow the financial systems for procurement and accounting.• Coordinate with cross functional team (regulatory,quality, packaging, quality department for alignment. • Coordinate with quality department for relevant alignments, analytical counterparts for routine and key deliverable activities.• Coordinate with PLM team with the help of delivery captain for program management related decision makings.• Support alliance management for evaluation of partners and contracts.• Manage communications with and monitor activities at external partner sites. Ensure to get the things done as per the program timelines and in compliance with quality and regulatory requirements.• Work ahead of time for planning and executing the tech transfer, clinical studies, submission preparation and query responses. • Coordinate for deficiency response in time. • Ensure compliance to documentation and other procedures.
