SENIOR MANAGER - ARD - R&D

Panaceabiotec; India; On-site; INR 6,000,000 - 9,000,000; Full time

Job summary

Panaceabiotec is seeking a Senior Manager - Analytical R&D to lead analytical method development for vaccines, biosimilars and biologics, ensuring robust upstream and downstream analytical workflows. You will oversee planning, supervision and review of all method development activities, ensuring data integrity, regulatory compliance and timely documentation.

The role requires a Post PhD with 12+ years of hands-on experience and expertise in HPLC/UPLC, LC-MS, CE, SEC-MALS, MS, CD and fluorescence

Qualifications

• Post PhD with 12+ years of experience in analytical R&D for vaccines, biosimilars or biologics.
• Expertise in analytical method development, qualification and validation at R&D scale.
• Knowledge of global regulatory standards such as cGMP, FDA, EMA.

Responsibilities

• Overall planning, design, supervision & review of analytical method development activities for vaccines, monoclonal antibodies and biologics.
• Maintain data integrity and ensure zero non-compliance in documentation.
• Coordinate cross-functional teams, sites and collaborators, ensuring timely output within budget.
• Provide guidance, motivation and feedback to team members and conduct performance reviews.
• Ensure compliance with safety and environmental regulations.

Education

Post PhD

Tools

HPLC/UPLC

LC-MS

Capillary Electrophoresis

SEC MALS

Mass Spectrometry

Circular Dichroism

Fluorescence spectroscopy

Job description

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

Designation - Senior Manager -Analytical R & D

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

Responsibilities

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