Senior Manager - Analytical Research & Development

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

Designation - Senior Manager - Analytical R & D

Job Summary - Overall in-charge for analytical R&D activities for vaccine candidate, biosimilar and biologicals.

Responsibilities

• Overall planning, design, supervision & review of all Analytical Method Development activities for characterization of vaccines candidate, monoclonal antibody and biologics including method development, qualification, and/or validation at R&D scale.
• Technical knowledge on different analytical methods including highly precise laboratory assays such as HPLC/UPLC, LC-MS, Capillary Electrophoresis (CE), SEC MALS, Mass Spectrometry, CD and Fluorescence spectroscopy.
• Maintaining thorough knowledge of global regulatory standards like cGMP (Current Good Manufacturing Practice), FDA, and EMA guidelines.
• Due-diligence for new R&D projects and extramural Grants as per Company's mission and vision.
• Ensure correct allocation of manpower and monitoring of assigned task with optimum output in a timely manner within allocated budgets.
• Ensure timely documentation including STPs, SOPs, Method development reports, as per required regulatory guidelines & expectations.
• Ensure zero non-compliance & absolute data integrity in documentation.
• Ensure effective communication and coordination with cross-functional teams, sites and collaborators.
• Provide timely guidance, motivation and feedback to team members for effective team work, performance and productivity.
• Effective Performance Reviews of the Team and their training needs.
• Driving various activities with strict adherence of safety and environmental regulations of the organization.

Qualifications

• PhD and M.SC in Biotechnology.
• Preferably from R&D setup.