Sr MANAGER - ARD - R&D

Experience Level: Post PhD - 12+ years of experience(Mandatory)

Designation - Senior Manager -Analytical R D

Job Summary - Overall in-charge for analyticalRD activities for vaccine candidate, biosimilar and biologicals.

Responsibilities

Overall planning, design, supervision review of allAnalytical Method Development activities for characterization of vaccinescandidate, monoclonal antibody and biologics including method development,qualification, and/or validation at RD scale.

Technical knowledge on different analytical methods includinghighly precise laboratory assays such as HPLC/UPLC, LC-MS, CapillaryElectrophoresis (CE), SEC MALS, Mass Spectrometry, CD and Fluorescencespectroscopy.

Maintaining thorough knowledge of global regulatory standards likecGMP (Current Good Manufacturing Practice), FDA, and EMA guidelines.

Due-diligence for new RD projects and extramural Grants asper Company's mission and vision.

Ensure correct allocation of manpower and monitoring of assignedtask with optimum output in a timely manner within allocated budgets.

Ensure timely documentation including STPs, SOPs, Methoddevelopment reports, as per required regulatory guidelines expectations.

Ensure zero non-compliance absolute data integrity indocumentation.

Ensure effective communication and coordination withcross-functional teams, sites and collaborators.

Provide timely guidance, motivation and feedback to team membersfor effective team work, performance and productivity.

Effective Performance Reviews of the Team and their training needs.

Driving various activities with strict adherence of safety andenvironmental regulations of the organization.

Qualifications

PhD and M.SC in Biotechnology.

Preferably from RD setup.

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