Panacea Biotec
Website:
panaceabiotec.com
Job details:
DESIGNATION - SENIOR MANAGER - ANALYTICAL RESEARCH & DEVELOPMENT
Experience - Post PhD + 8 to 10 years of experience
Job Summary - Overall in-charge for analytical R&D activities for vaccine candidate, biosimilar and biologicals.
Qualifications:
● PhD/M.SC in Biotechnology.
● Preferably from R&D setup.
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.
Click on Apply to know more.
