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 Positive 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.
📌 Senior Manager - Analytical Research & Development (Delhi)
🏢 Panacea Biotec
📍 Delhi
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