Job for M.Pharm, Ph.D to work as Group Leader in Injectable Development at Syngene International
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Group Leader - Injectable Development
JOB SUMMARY: Drive projects and communicate with clients for various activities and updates. Coordination with BD for business development activities. Responsible for team management and project management. Responsible to ensure functional budget within targets. Monitor and enhance overall functioning of individual teams including implementation of systems and procedures.
- Lead the teams for Product Development function, for formulation development of parenterals/Injectables (lyophilized and ready to use, small molecule and biologics), critical review and approval of protocols and reports.
- Responsible for Project planning, execution and revenue tracking of assigned projects.
- Responsible for proposal write up.
- Responsible for client relation management i.e. attending telecons, report submission.
- Taking corrective actions, making key decisions to ensure project is delivered on time and within the allocated budget without compromising on quality.
- Interact with clients and staff to develop strategies, interpret data and to guide analyses.
- Coordination with concerned HODs for proposal writing and get it reviewed by them.
- Responsible for formulation and process development for various projects and ensure every activity happens within the project scope.
- Support to client and regulatory audit.
- Manage, train and mentor team members.
- Responsible for enhancing productivity and team building
- Ensure that individual team member adheres and follows the systems and SOPs and provide training for the same
- He/She will also be responsible for ensuring GMP and HSE related requirements within function
- Cross-functional co-ordination for various projects and facility related activities
Ph. D. in Pharmaceutics M Pharm in Pharmaceutics
Ph.D: 12+ years of experience
M Pharm: 16+ years of experience
TECHNICAL /FUNCTIONAL SKILLS:
• Experience on formulation and process development i.e. parenterals. (lyophilized and ready to use)
• Hands on experience in PFS and lyophilization cycle development
• Indepth knowledge on regulatory guidelines and knowledge of cGMP manufacturing.
• In-depth knowledge in scale up and technology transfer.
• Project Management skills
• Multitask effectively while leading multiple formulation development projects
• Experience with parenteral development of small molecules a must. Experience with Large molecules a plus (desired).
• Experience with NDDS a plus
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