Execution of analytical method optimization, development, validation, verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management studies, Supplier Driven Changes and other procedural updations.Preparation of method validation/verification protocols and reports.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment internally and with external partners. Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings and strong problem-solving skills.
Proven track record of documentation review for accuracy and compliance to procedures essentially in analytical methods development, validation, transfer, stability studies, Design & Development.
Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.
M.Sc. Biotechnology, M.Pharm, Biotechnology with first class and preferably GPAT qualified. Experience in cell culture, basic molecular biology techniques
Good knowledge in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine reconciliations and compliance checks and communicating standard information to Third Parties as required with appropriate guidance.
M.Sc. / M Pharm / PhD. Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.