Head of Product Development and Technology

About BioGenex

BioGenex designs, develops and commercializes molecular pathology systems for tumor diagnosis, prognosis, precision medicine and life science research. Its business combines automated molecular pathology workstations with antibodies, probes, detection systems, retrieval solutions, histology stains, reagents and consumables for immunohistochemistry, in situ hybridization, fluorescence in situ hybridization, multiplex staining, microRNA and related tissue-based applications. BioGenex serves pathologists, histotechnologists, clinical and reference laboratories, biotechnology and pharmaceutical organizations, and academic researchers.

About the Role

BioGenex is looking for a Technical / Functional Head to direct product development and technical operations across molecular pathology, laboratory automation and regulated diagnostic systems. The role will align scientific R&D, engineering, software and firmware, verification and validation, manufacturing transfer and technical program management around a common product roadmap.

The position is accountable for converting business, customer and clinical needs into reliable, compliant and commercially relevant products from concept through lifecycle support. The incumbent will set technical priorities, allocate resources, manage portfolio risks, develop leaders and communicate decisions to senior leadership. This is not a coding position, but it requires the ability to guide software teams, review architecture and development plans, assess technical risks, and ensure appropriate verification, validation and release controls.

Key Responsibilities

·Define and execute the product and technology strategy, roadmap and investment priorities, including decisions on external technologies, collaborations and strategic partnerships.

·Translate clinical needs, pathology laboratory workflows, customer feedback and business priorities into clear product requirements and development programs.

·Direct scientific product development across histology, FFPE workflows, IHC, ISH, FISH, multiplex staining, RNA and miRNA detection, and related tissue-based applications, ensuring appropriate analytical performance and scientific evidence.

·Lead integrated systems development across mechanical engineering, electronics, thermal control, fluidics, motion control, embedded firmware, product software, reagents and consumables.

·Lead product software and firmware through qualified managers, with oversight of architecture, development planning, cybersecurity, interfaces, testing, configuration management, release control and maintenance.

·Establish technical governance covering system architecture, requirements traceability, product risk, design reviews, stage gates, escalation paths and release readiness decisions.

·Own technical portfolio plans, departmental budgets, headcount, milestones, resource allocation, external partners, vendors, major risks and executive reporting.

·Ensure that integrated verification and validation plans, test methods, acceptance criteria, traceability and objective evidence cover the complete product and workflow.

·Lead design transfer and manufacturing readiness, including product specifications, bills of materials, drawings, software versions, calibration, supplier qualification, pilot builds and process validation.

·Partner with Manufacturing and Quality to improve yield, product consistency, cost, reliability and serviceability, and to resolve significant production and field performance issues.

·Partner with Quality Assurance and Regulatory Affairs on design controls, product risk management, technical documentation, regulatory submissions, product claims, CAPA and post-market activities.

·Recruit, develop and retain scientific, engineering, software and program management leaders; set objectives, review performance and build succession plans.

Key Technical Areas

· Molecular and tissue-based diagnostics

· Embedded firmware and product software

· Histology and FFPE workflows

· Software lifecycle and cybersecurity

· IHC, ISH and FISH

· Risk management and design controls

· Multiplex and spatial biology

· Verification and validation

· Antibodies, probes and detection chemistry

· Technology transfer and scale up

· Analytical and performance validation

· Instrument and reagent manufacturing

· Systems engineering and requirements

· Reliability, serviceability and CAPA

· Mechanical, electronics and fluidics

· ISO 13485 quality systems

Requirements

Qualifications

·Master's degree or doctorate in molecular pathology, molecular biology, biotechnology, biochemistry, biomedical engineering, medical device engineering or a related discipline; an additional qualification in management, operations or business is advantageous.

·Strong scientific foundation in tissue-based diagnostics, molecular pathology, assay development or pathology laboratory automation.

Experience

·At least 15 years of experience in IVD, molecular diagnostics, pathology automation, life science instruments, biotechnology or regulated medical devices, including eight or more years in progressively senior leadership roles.

·A record of leading managers and multidisciplinary technical teams spanning scientific R&D, engineering, software, verification and validation, and technical program management.

·Successful delivery of integrated instrument, reagent, assay, consumable and software products from concept through commercialization and lifecycle support.

·Strong knowledge of tissue-based diagnostics or related cancer testing technologies, including FFPE workflows, histology, IHC, ISH, FISH, multiplex staining, biomarkers and analytical performance.

·Experience leading complex systems and software development, including the ability to evaluate architecture, development plans, technical risks, testing and release readiness without serving as the primary coder.

·Experience in an ISO 13485 or comparable regulated environment, including design controls, product risk management, traceability, verification and validation, change control, CAPA and regulatory submission support.

·Demonstrated success with design transfer, production scale up, supplier and process readiness, product reliability, serviceability and resolution of manufacturing or field performance issues.

·Experience managing product portfolios, budgets, headcount, external partners and resource trade-offs, and presenting investment needs, product readiness and major risks to senior leadership.

Preferred Experience

· Automated slide staining systems

· FDA QMSR and EU IVDR

· Pathology laboratory workflows

· India Medical Devices Rules

· IHC, ISH and FISH product development

· IEC 62304 and IEC 61010

· Integrated instrument and reagent systems

· LIMS and laboratory connectivity

· Global IVD commercialization

· Global and distributed technical teams

Key Competencies

· Scientific and technical leadership

· Software team leadership

· Product and systems thinking

· Quality and regulatory judgment

· Portfolio and program management

· Cross functional collaboration

· Analytical problem solving

· Executive communication

· Risk based decision making

· Talent development

· Manufacturing and design transfer

· Commercial and customer orientation

Benefits

• 5 Day Work Week
  
• Health & Accidental Insurance
  
• Leave Encashment
  
• Provident Fund
  
• Free Commute