Senior Manager - Analytical Research & Development

Panacea Biotec; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Panacea Biotec is seeking a Senior Manager - Analytical R&D to oversee analytical method development for vaccines, biosimilars, and biologics. You will lead the design, supervision, and review of all analytical activities at R&D scale, ensuring compliance with cGMP and global regulatory standards.

The role requires 12+ years of post-PhD experience, preferably from an R&D setup, with strong expertise in HPLC/UPLC, LC-MS and other analytical techniques.

Qualifications

• PhD and MSc in Biotechnology.
• Preferably from an R&D setup.

Responsibilities

• Overall planning, design, supervision and review of analytical method development for vaccine candidates, monoclonal antibodies and biologics.
• Maintain knowledge of regulatory standards like cGMP, FDA and EMA guidelines.
• Ensure timely documentation (STPs, SOPs, reports) with data integrity.
• Provide guidance, motivation and performance reviews to the team.
• Coordinate with cross-functional teams and sites to meet budgets and timelines.

Skills

Team leadership

Project management

Regulatory compliance

Strategic planning

Education

PhD in Biotechnology

MSc in Biotechnology

Tools

HPLC/UPLC

LC-MS

Capillary Electrophoresis

SEC MALS

Mass Spectrometry

CD Spectroscopy

Fluorescence spectroscopy

Job description

Job description:

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.