Senior Lead/ Senior Manager

Sampoorna Consultants; Bengaluru; On-site; INR 3,200,000 - 4,800,000; Full time

Job summary

Sampoorna Computer People seeks a Senior Lead/Senior Manager to drive diagnostics pipeline end-to-end in the life sciences domain. Responsibilities include steering design transfer, verification/validation, regulatory filings (CDSCO, CE-IVD/IVDR), and building external partnerships with hospitals, labs, and CROs to secure samples and run validations.

Strong project management and analytical skills are essential.

Qualifications

• Degree in life sciences or related field; advanced degree preferred.
• 5–8 years with molecular diagnostics kit development and launch experience.
• Experience managing multi-stakeholder projects to deadlines.
• Knowledge of ISO 13485 is a plus.

Responsibilities

• Own the diagnostics pipeline end-to-end from feasibility to launch.
• Drive IVD kits through design transfer, verification, validation, and regulatory filings.
• Build external partnerships with hospitals, labs, and KOLs for samples and validations.
• Design and manage performance studies and data analyses.
• Coordinate across R&D, Manufacturing, QA/RA, and Commercial to clear bottlenecks.
• Build dashboards tracking pipeline status, timelines, and costs.
• Run program reviews and provide updates to leadership, partners, and funders.

Skills

Project management

Analytical skills

Stakeholder management

Partner-facing roles

Communication skills

PMP certification

Education

Bachelor’s or above in life sciences, biotechnology, or molecular biology

Master’s or PhD preferred

Job description

Senior Lead/ Senior Manager - J50963

Role & responsibilities

• Own the diagnostics pipeline end-to-endtimelines, milestones, risks, and resources from feasibility to launch.
• Drive IVD kits through design transfer, verification and validation, and regulatory filings (CDSCO, CE-IVDR).
• Build external partnerships with hospitals, labs, and KOLs to secure samples, run validations, demos, and studies.
• Design and manage performance studies—protocols, site coordination, data analysis, and reports.
• Coordinate across R&D, Manufacturing, QA/RA, and Commercial to clear bottlenecks and speed up decisions.
• Build dashboards on pipeline status, timelines, and cost; flag risks early.
• Run program reviews and prepare updates for leadership, partners, and funders.

Qualifications

• Science background (must have): Bachelor’s or above in life sciences, biotechnology, or molecular biology; Master’s or PhD preferred
• 5 - 8 years’ experience in molecular diagnostics kit development (IVD) and launch across Indian (CDSCO) and European (CE-IVD/IVDR) pathways is a MUST
• Project management experience running multi-stakeholder programs to deadline in diagnostics or life sciences is a MUST
• Working knowledge of clinical performance studies and ISO 13485 quality systems will be an added advantage
• Excellent analytical skills; comfortable with data, timelines, and trade-offs
• Confident in partner-facing roles; network with hospitals, labs, or CROs a plus
• PMP certification will be an added advantage