Posted:1 day ago|
Platform:
Work from Office
Full Time
Recruit, mentor, and lead a cross-functional team (biophysicists, protein scientists, analysts, lab technicians), foster team development and ensure high performance.
Oversee resource planning: instrumentation, consumables, lab maintenance, compliance (GLP, ISO/NABL, FDA where relevant).
Manage budgets, cost-recovery, profitability, and business metrics for the division.
Scientific & Technical Oversight
Oversee and ensure quality of structural characterization assays(full list here -
Ensure all assays are validated (or validated where applicable) under GLP/ISO 17025 compliance regime; maintain robust SOPs and documentation. Regulatory awareness
Collaborate with quality and project management teams to support biosimilar/biologic development pipelines from early characterization to release testing or comparcanability batches.
Drive continuous improvement: adopt new and orthogonal methods, stay updated on latest structural/biophysical technologies, evaluate addition of new assays or instrumentation.
Oversee project planning, prioritization, method development or method adaptation, scheduling, delivery timelines, and client communication.
Ensure documentation, reporting, and data integrity for each project; ensure compliance with GLP, QA, and accreditation requirements (e.g. NABL / ISO standards, as relevant to CBA).
Facilitate standardization of methods, knowledge sharing, lab-best practices, troubleshooting framework, backlog management.Contribute to business development: collaborate on proposals, support outreach to potential clients/startups, help define service packages and pricing.
Implement robust data management, documentation, change control, SOP review, instrument validation/calibration, audit readiness.
Establish metrics for lab performance, turnaround time (TAT), service quality, customer satisfaction, instrument utilization.
Advanced degree (PhD preferred) in Structural Biology / Biochemistry / Biophysics / Protein Chemistry / Biotechnology or related field.
Significant experience (ideally 8 15+ years) in structural biology, protein characterization, biopharma analytics or biologics development including hands-on experience with techniques like mass spectrometry, CD/FTIR/fluorescence spectroscopy, DSC, size-exclusion, glycan analysis, SPR.
Proven track record of building or managing a structural/biophysical or bioanalytical lab/division (or equivalent leadership roles) team management, budgeting, project management.
Strong understanding of regulatory requirements, QC/QA, validation methods, GLP workflows, and documentation norms (particularly relevant for GLP-compliant testing services).
Excellent problem-solving skills, ability to troubleshoot complex scientific assays, manage multiple projects, and deliver under deadlines
Good communication and client-facing skills able to liaise with external stakeholders (startups, industry, academia), explain technical aspects, draft proposals, and translate client requirements into assay strategies.
Strong organizational skills, ability to manage resources (instruments, consumables, lab personnel), and maintain documentation, QA/QC compliance.
Preferred / Nice-to-Have
Prior experience working in a CRO, biopharma lab, or characterization services environment.
Experience in biosimilar characterization, comparability studies, regulatory-compliant analytics.
Familiarity with business development for lab services, cost-recovery models, client engagement, and service-oriented delivery.
Publication record (for credibility); experience in cross-functional collaboration (with upstream process development, regulatory, formulation teams).
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