Assistant/Dy. Manager – R&D Clinical Serology | Biological E | Hyderabad

Job Description

Formulation Development Manager (Vaccines)

Roles and Responsibilities

• Method development, qualification, and validation of ELISA for Clinical Study along with generation and/or qualification of reference sera and critical reagents.
• Performing cell culture-based assays and virus-based neutralization assays. Writing SOPs, QMS documents, reports, and protocols.
• Managing inventory for equipment and laboratory consumables/reagents. Cross-functional interaction with QC, QA, Regulatory, Clinical, and other R&D departments.
• ELISA, Cell-based assays, Flow Cytometry, Surface Plasmon Resonance, Multiplex assays in Luminex /MSD platform, PK/PD-ADA assays.

Candidate desirable skills:

• Knowledge in Immunology and Vaccine development with experience in Serological techniques, Cell-based bioassays, Flow Cytometry, Viral Neutralization assays, Multiplex Binding assays, ELISA, Surface Plasmon Resonance, etc.
• Understanding Clinical/Pre-clinical sample analysis and CRO management will be of additional advantage.
• GLP-level documentation practices along with good communication and analytical skill are required.
• Extensive experience in Method Development, Method Validation, and Technology Transfer within and outside the organization is desirable.
• The position demands the candidate to work in a team and also function across multiple disciplines as per the project request. Someone proactive in learning and fast at adapting to new techniques would be a desired candidate.

Function: Vaccine R&D

Department: Clinical Serology

Designation: Assistant/ Deputy Manager

Educational Qualification: B.Tech/ M.Sc/ M.Tech (Lifesciences)

Experience: 7-10 years