from 15 to 20 year(s) of Experience
INR 45,00,000 - 55,00,000 PA.
Supervise Program Leaders and teams composed of members from multiple functions and be accountable for the timely execution of biologics development and manufacturing projects. Projects span from cell line development to drug product development and commercial manufacturing.
Work with individual Program Leaders, Program Managers and clients in clarifying project goals and executing them. Monitor the progress of projects as per established timelines. Devise, implement and monitor team efficiency metrics.
Understand key project/ client requirements and communicate these internally and externally. Interact with clients regularly and drive project execution to satisfy internal and external requirements as per established timelines.
Supervise Program Leaders and organize weekly meetings/ teleconferences with clients; follow up on action items internally; report project progress to clients and discuss technical aspects to design path forward.
Supervise and monitor weekly internal project review meetings; follow up on action items with the team; inform team of project progress and discuss technical aspects to design path forward; report project progress internally to senior management.
Guide Program Leaders, Program Managers and project teams in development, scale up and technology transfer operations. Provide substantial technical inputs and lead team members in designing experiments, analyzing and interpreting data as well as in arriving at appropriate conclusions.
Work with multiple department heads to ensure that each project team and members are enabled to execute the required developmental and manufacturing work including upstream, downstream and drug product development. Organize additional internal meetings as necessary to support developmental and manufacturing work.
Guide the review and sign-off on documentation of the project teams including experimental plans, client interactions including minutes-of-meeting, development reports, manufacturing batch records and regulatory documents.
Work with Quality Assurance and Regulatory departments to ensure a smooth operation from project inception to development to manufacturing. Follow up internally and externally, on required regulatory items. Develop the team’s regulatory awareness.
Guide/work with Development, Plant and Quality Control personnel in ensuring the appropriate use of raw materials, consumables and equipment, and in providing cost effective solutions, where possible.
Ph.D/M.Tech- Biochemical Engineering/ Biotechnology/ Chemical engineering
- An ability to understand key project/client requirements and communicate these internally and externally.
- Demonstrated, long-term, ability or expertise in at least one unit operation as related to biologics process development and/or manufacturing including upstream, downstream and drug product development.
- Scale up, Technology transfer, Process validation and CMC package development experience is preferred.
- Hands-on experience in working with bio-pharmaceutical/ biologics equipment at laboratory and manufacturing scales.
- Ability to identify issues, think scientifically and investigate complex problems, analyze data and public domain information, and communicate to clients and senior management.
- Excellent communication skills are critical.
- Possess the knowledge and exposure to environment, health, and safety (EHS) practices
- Ensure the development of effective environment, health, and safety (EHS) practices for the company and oversee compliance with those practices
- Foster a corporate culture that promotes environment, health, and safety (EHS) mindset at workplace
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.
15-20 years post qualification
Should have the capability to work in a team and ability to handle demonstrate a good team spirit.
While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.
Should be proactive while working on allotted responsibility.
Contact Company:BVR People Consulting