Head of Commercialization and Operations, New Approach Methodologies (NAMs) (New Delhi)

Head of Commercialization and Operations, New Approach Methodologies (NAMs) (New Delhi)

14 Oct
|
NITS Engineering
|
New Delhi

14 Oct

NITS Engineering

New Delhi

Head of Commercialization and Operations, Recent Approach Methodologies (NAMs)

Location: New Delhi, India

Employment Type: Full time

Reports to: Founders and Board

About NITS EngineeringNITS Engineering is a biomedical technology company building the next generation of biomedical devices, in vitro disease models, and engineering systems for drug discovery, regenerative medicine, and diagnostics. We combine precision hardware engineering with biomedical research to build the tools that take science from the lab bench to real world application.

Role OverviewRegulators worldwide are reducing reliance on animal testing, and drug developers need human relevant models they trust. We are building high throughput bioprinted human tissue platforms, starting with engineered cardiac tissue, for safety assessment, disease modeling, and drug discovery.

We are seeking a commercial and operational leader who has taken NAMs to market. You will own the path from validated science to revenue: defining products and pricing, winning pilots and first contracts with pharma, biotech, and CROs, shaping the validation evidence customers require, and building the operations that deliver reliably at scale. This work is carried out in collaboration with CenFab, the Center for Biofabrication at Vellore Institute of Technology, Vellore.

What You Will DoGo to Market and Revenue

- Define product offerings, target customer segments, and the business model (assay services, kits, or platform licensing).
- Set pricing for pilot studies, service contracts, and platform access.
- Build and manage the pipeline: lead pilot evaluations, convert them into paid contracts, and establish recurring revenue.
- Secure partnerships with pharma, biotech, CROs, distributors, and academic centers in India, the US, and Europe.
- Deliver the first commercial milestones:



paid pilots in year one and recurring contracts by year two.

Validation That Drives Adoption

- Work with the R&D; team to design validation studies that answer the questions buyers and regulators ask, including reference compound sets, sensitivity, specificity, and reproducibility.
- Benchmark our models against human clinical data, animal data, and incumbent in vitro assays to build a clear value case.
- Align the evidence package with FDA, EMA, CDSCO, and OECD expectations, and decide when to pursue formal qualification routes.
- Translate customer feedback into product requirements and specifications.

Operations and Quality

- Build the quality management system for commercial model production, including SOPs, batch release criteria, and documentation suitable for customer audits.
- Establish supply chain and vendor management for cells, reagents, and consumables, including import planning.
- Set up service delivery workflows, timelines, and data reporting standards for customer projects.
- Scale capacity in step with demand while maintaining batch to batch consistency.

Leadership and External Engagement

- Lead business development, project management, and operations staff, working closely with scientific teams.
- Represent NITS Engineering at industry conferences, NAM consortia, and investor meetings.
- Prepare commercial proposals, study designs, white papers, and pitch materials.




- Support fundraising and nondilutive grant applications with market and commercial strategy.

What We Are Looking For

- At least 8 years of professional experience, with at least 4 years commercializing NAMs, in vitro models, or preclinical services in industry.
- A proven record of selling NAM products or services to pharma, biotech, or CROs, with demonstrable contract values and customer relationships.
- Experience setting pricing, running pilot to contract conversion, and negotiating commercial agreements.
- Hands-on experience building operations or quality systems (ISO 9001, ISO 13485, or GLP) for an assay, model, or product.
- Working knowledge of at least one NAM domain: microphysiological systems, organoids, 3D tissue models, iPSC derived assays, or in silico safety tools.
- A scientific degree in a relevant discipline. A PhD, MBA, or both is valued but not required.
- Strong network across pharma safety and discovery teams, CROs, and the NAM community.

Nice to Have

- Contributions to regulatory or validation initiatives with FDA, EMA, NIH/NICEATM, EURL ECVAM, OECD, or CDSCO.
- Experience commercializing 3D bioprinted or cardiac models.
- Experience managing multilab reproducibility studies or technology transfer to customer sites.
- Experience at a startup or early stage company through first revenue or fundraising.

Why Join

- Lead the commercial launch of human relevant NAM platforms from first customer to scale.
- Shape a company at an early stage, with direct influence on strategy, products, and growth.
- Work alongside biomedical engineers and cell biologists in a multidisciplinary environment, with access to the CenFab biofabrication hub.
- Help modernize preclinical testing and reduce reliance on animal studies.

📌 Head of Commercialization and Operations, New Approach Methodologies (NAMs) (New Delhi)
🏢 NITS Engineering
📍 New Delhi

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