Role Description

This is a full-time on-site role for a Regulatory Specialist. The Regulatory Specialist will be responsible
for ensuring regulatory compliance, staying up-to-date with regulatory requirements, and utilizing
analytical skills to identify potential issues. The Regulatory Specialist will also be responsible for
communicating with regulatory agencies and providing regulatory affairs support to other teams.

Designation: RA Specialist (US-FDA)
Job Department: Regulatory Affairs
Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
Regulatory Experience: Minimum 3 years in US FDA/ MDSAP/ 510 K submission
Industry/ Background – Medical Device /Pharma/Lifesciences Industry
Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
Employment Status: Permanent
Job Location: Chennai
Workplace Type: On-site

Minimum Requirements:

• Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation.
• Understanding of cGMP and US FDA guidelines.
• Ability to effectively present information to management and other groups
• Experience in preparing and managing regulatory dossiers, including DMFs, INDs, MAAs, and
  other regulatory submissions.
• Excellent understanding of pharmaceutical product development processes, manufacturing,
  and quality control.
• Strong attention to detail and accuracy in documentation and data management.
• Effective communication and interpersonal skills, with the ability to collaborate with crossfunctional teams and interact with regulatory authorities.
• Proficiency in using regulatory affairs software, document management systems, and
• Microsoft Office Suite.
• Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced and
  dynamic environment.
• Knowledge of international regulatory requirements and experience with Health Canada/
• Brazil/ Japan/ USFDA/ Australia regulatory submissions is a plus.
• Certification or training in USFDA/ Other Regulatory affairs is preferred

Roles and Responsibilities

• The candidate will be responsible for handling and following of Regulatory process of USFDA
  / 510 K Submission.
• Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA) and
  other global regulatory agencies.
• Review and interpret regulatory guidelines and communicate updates and changes to
  internal stakeholders.
• Coordinate with cross-functional teams, including R&D quality assurance, and
  manufacturing, to gather necessary information and documentation for dossier preparation.
• Collaborate with regulatory authorities and agencies to address queries, provide additional
  information, and facilitate dossier review processes.
• Stay updated with evolving regulatory requirements and industry trends related to USFDA.
• Assist in the preparation and submission of post-approval regulatory filings, variations, and
  renewal applications.
• Prepares all product listing, facility registration, product label updates, and facility
  identification for submission to the US FDA.
• Support and coordinate for MDSAP / ISO 13485 / QMS Audits, Internal Audits, and
• Complaints and CAPA process.
• Responsible for verifying specification of excipients, active, finished product and packaging
  material, and all required documents.

Send your resume to: [email protected]

Role Description:

We are seeking a Quality Control (QC) Manager to oversee product testing, quality analysis, and
compliance with regulatory standards. The QC Manager will be responsible for ensuring the integrity
of raw materials, in-process materials, and finished products.

Designation: QC Manager
Department: Quality Control
Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry
Regulatory Experience: Minimum 3-5 years in GMP, US FDA, ISO 13485, and Analytical Testing
Industry/Background: Medical Device / Pharma / Lifesciences Industry
Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field
Employment Status: Permanent
Workplace Type: On-site

Minimum Requirements:

• Strong knowledge of analytical techniques, stability studies, and microbiology testing.
• Experience in handling QC documentation, test reports, and specifications.
• Proficiency in GMP, ISO 13485, US FDA, and MDSAP compliance.
• Expertise in using HPLC, GC, UV, and other analytical instruments.
• Experience in raw material, in-process, and finished product testing.
• Strong knowledge of deviation handling, OOS investigations, and CAPA.
• Ability to lead a QC laboratory and ensure smooth functioning of testing operations.

Roles and Responsibilities:

• Oversee quality control operations and ensure compliance with regulatory standards.
• Ensure proper testing and validation of raw materials, in-process, and finished products.
• Review and approve test reports, analytical data, and quality records.
• Monitor and maintain stability studies and analytical testing procedures.
• Conduct investigations for out-of-specification (OOS) results and deviations.
• Ensure the calibration and maintenance of laboratory instruments.
• Coordinate with cross-functional teams to ensure product quality.
• Support regulatory submissions and participate in regulatory inspections.

Send your resume to: [email protected]

Role Description:

We are seeking a Quality Assurance (QA) Manager to oversee and ensure compliance with quality
standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role requires
strong expertise in Quality Management Systems (QMS), audits, and process improvements.

Designation: QA Manager
Department: Quality Assurance
Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry
Regulatory Experience: Minimum 3-5 years in ISO 13485, MDSAP, US FDA, GMP Compliance
Industry/Background: Medical Device / Pharma / Lifesciences Industry
Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field
Employment Status: Permanent
Workplace Type: On-site

Minimum Requirements:

• Strong knowledge of ISO 13485, QMS, MDSAP, and US FDA guidelines.
• Experience in conducting and facing regulatory audits (MDSAP, FDA, ISO).
• Expertise in quality documentation, deviation handling, and CAPA.
• Experience in risk management, validation, and qualification processes.
• Ability to lead and coordinate internal and external audits.
• Experience in handling change control, non-conformances, and product recalls.
• Strong communication and leadership skills.

Roles and Responsibilities:

• Develop and implement Quality Management Systems (QMS) as per regulatory guidelines.
• Ensure compliance with GMP, US FDA, MDSAP, and ISO 13485.
• Conduct and lead internal audits, external audits, and supplier audits.
• Oversee CAPA, deviations, complaints, and non-conformances.
• Ensure proper documentation and timely submission of regulatory reports.
• Provide training and guidance to teams on quality procedures.
• Collaborate with cross-functional teams to ensure product quality and compliance.
• Support regulatory filings and post-approval compliance activities.|

Send your resume to: [email protected]

Role Description:

We are seeking a Design Engineer with a Mechanical Engineering background to work on product
design and development. The ideal candidate should have expertise in SolidWorks and experience in
designing components for the medical device, biotech, or life sciences industry.

Designation: Design Engineer
Department: Product Design & Development
Experience: Minimum 2 years in design engineering
Industry/Background: Mechanical / Medical Device / Pharma / Lifesciences Industry
Software Expertise: SolidWorks (mandatory), AutoCAD (preferred)
Qualification: B.E / B.Tech Mechanical Engineering or related field
Employment Status: Permanent
Workplace Type: On-site

Minimum Requirements:

• Minimum 2 years of experience in product design and development.
• Strong proficiency in SolidWorks for 3D modeling, drafting, and assembly design.
• Experience in designing plastic and metal components, sheet metal, and machined parts.
• Knowledge of GD&T, tolerance analysis, and material selection.
• Understanding of manufacturing processes, prototyping, and DFM/DFA principles.
• Ability to read and interpret engineering drawings.
• Exposure to ISO 13485 and medical device design standards is a plus.
• Strong problem-solving and analytical skills.
• Good communication and teamwork skills.

Roles and Responsibilities:

• Design and develop medical devices and accessories as per industry standards.
• Create and modify 3D models, technical drawings, and assemblies using SolidWorks.
• Conduct DFM (Design for Manufacturing) and DFA (Design for Assembly) analysis.
• Work closely with R&D, production, and quality teams to ensure product feasibility.
• Prepare technical documentation, BOMs, and design reports.
• Collaborate with vendors and suppliers for prototyping and manufacturing feasibility.
• Support testing, validation, and regulatory documentation for product approvals.
• Ensure compliance with ISO 13485 and regulatory standards for medical devices.

Send your resume to: [email protected]

Role Description:

We are seeking an Electrical Maintenance Engineer with expertise in HVAC, compressors, utilities
management, and machine installation. The ideal candidate should have a strong electrical
engineering background, with a C License as an added advantage.

Designation: Electrical Maintenance Engineer
Department: Engineering & Maintenance
Experience: Minimum 5 years in electrical maintenance
Industry/Background: Manufacturing / Medical Device / Pharma / Life Sciences Industry
Qualification: Diploma / B.E / B.Tech in Electrical Engineering
Licenses (Preferred): C License (added advantage)
Employment Status: Permanent
Workplace Type: On-site

Minimum Requirements:

• Minimum 5 years of experience in electrical maintenance and utilities handling.
• Strong knowledge of HVAC systems, air compressors, DG sets, chillers, boilers, and other
  utilities.
• Experience in machine installation, troubleshooting, and preventive maintenance.
• Understanding of electrical circuits, wiring, PLCs, and control panels.
• Hands-on experience in power distribution, LT/HT panels, and transformers.
• Familiarity with safety regulations, electrical codes, and GMP compliance.
• Knowledge of breakdown analysis, root cause identification, and corrective actions.
• Ability to read electrical schematics and technical drawings.
• Good problem-solving skills and ability to work in a fast-paced environment.

Roles and Responsibilities:

• Oversee and execute preventive, predictive, and corrective maintenance of electrical
  systems and utilities.
• Maintain and troubleshoot HVAC, compressors, DG sets, chillers, boilers, and other utility
  systems.
• Supervise and assist in the installation and commissioning of new machines.
• Monitor power distribution systems, LT/HT panels, and transformers for efficiency and
  safety.
• Ensure compliance with electrical safety regulations and standards.
• Coordinate with vendors and contractors for maintenance and repair work.
• Maintain proper documentation of maintenance schedules, reports, and breakdown
  analyses.
• Assist in audits related to electrical safety, compliance, and GMP standards.

Send your resume to: [email protected]

Role Description:

We are seeking a Clean Room Technician to support production and manufacturing operations in a
controlled cleanroom environment. The ideal candidate should have basic mechanical aptitude and
be willing to work in shifts as per production requirements.

Designation: Clean Room Technician
Department: Production / Manufacturing
Experience: Freshers & Experienced Candidates Can Apply
Industry/Background: Medical Device / Pharma / Lifesciences / Manufacturing
Qualification: ITI / Diploma in Mechanical, Electrical, or Production Engineering
Employment Status: Permanent
Workplace Type: On-site

Minimum Requirements:

• ITI or Diploma in a relevant field (Mechanical, Electrical, or Production Engineering).
• Freshers and experienced candidates are welcome to apply.
• Willingness to work in shifts as per production requirements.
• Basic mechanical aptitude and ability to learn machine operations.
• Ability to follow cleanroom protocols, safety guidelines, and standard operating procedures
  (SOPs).
• Understanding of basic tools, equipment handling, and material flow in production.Attention to detail and ability to work in a sterile and contamination-free environment.

Roles and Responsibilities:

• Operate and maintain cleanroom machinery and equipment as per SOPs.
• Follow GMP guidelines and cleanroom protocols to ensure product quality.
• Handle raw materials, components, and finished products in a contamination-free manner.
• Monitor and maintain cleanroom cleanliness, air filtration systems, and safety standards.
• Perform routine inspections, documentation, and reporting of production activities.
• Assist in machine setup, troubleshooting, and preventive maintenance.
• Work closely with production supervisors and quality teams to meet manufacturing goals.
• Adhere to safety regulations and participate in continuous improvement activities.

Send your resume to: [email protected]

Roles and Responsibilities:

• Develop and execute strategic sales plans to achieve revenue targets for Single Use CGT
  Therapy.
• Identify key clients and prospects, including hospitals, clinics, and pharmaceutical
  companies.
• Lead and manage the sales team, providing guidance to achieve individual and team targets.
• Build and maintain relationships with key stakeholders, partners, and customers.
• Conduct market research to track trends and competitor activities.
• Negotiate contracts, pricing, and terms with customers.
• Monitor and report sales performance, adjusting strategies as needed.
• Work closely with the marketing team to develop targeted promotional campaigns.
• Oversee post-sales support to ensure customer satisfaction and retention.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Biotechnology, Life Sciences, Bioprocessing, or Business
  Administration.
• 5+ years of experience in sales and business development in the Biopharma / Life Sciences
  sector.
• Strong understanding of Single Use CGT Therapy and related technologies.
• Excellent negotiation, communication, and leadership skills.
• Willingness to travel across regions

Send your resume to: [email protected]

Roles and Responsibilities:

• Develop and execute sales strategies to achieve annual revenue targets.
• Identify and target pharmaceutical manufacturers, biotech companies, and research labs.
• Build relationships with key decision-makers to influence purchase decisions.
• Coordinate with the global sales team to align strategies with international markets.
• Provide sales forecasts, market intelligence, and competitor analysis.
• Lead sales efforts, including lead qualification, proposal development, and deal closure.
• Work closely with the technical team to provide customer insights for product development.
• Ensure compliance with sales processes and regulatory standards.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Biotechnology, Bioprocessing, or related fields.
• 5+ years of sales experience in the biopharmaceutical sector.
• Knowledge of Single Use Bioprocessing solutions.
• Strong market research and customer relationship skills.
• Willingness to travel within India

Send your resume to: [email protected]

Roles and Responsibilities:

• Develop and implement export sales strategies for Single Use Bioprocessing solutions.
• Identify new export markets and build strong client relationships.
• Collaborate with international teams to align sales strategies with global market trends.
• Provide sales forecasts and export market intelligence to senior management.
• Lead sales efforts, including identifying opportunities, qualifying leads, and closing deals.
• Work closely with technical and product teams for customization and client-specific needs.
• Ensure compliance with export regulations and industry standards.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Biotechnology, Bioprocessing, or Life Sciences.
• 5+ years of experience in international sales and exports.
• Strong knowledge of global markets (APAC, Europe, MECISA).
• Excellent negotiation and communication skills.
• Willingness to travel internationally.

Send your resume to: [email protected]

Roles and Responsibilities:

• Expand market presence for CGT Single Use Solutions in international markets.
• Support the sales team with administrative and logistical coordination.
• Conduct market research and track competitor activities.
• Generate and qualify leads in international markets and convert them into customers.
• Build and maintain relationships with key clients through follow-ups and support.
• Assist in sales presentations, product demos, and proposals.
• Maintain accurate sales records, contracts, and pricing agreements.
• Collaborate with the marketing and logistics teams for smooth sales execution.
• Manage CRM and sales pipeline, providing regular updates to the management team.
• Participate in trade shows, exhibitions, and international conferences.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Business, Biotechnology, or Life Sciences.
• 2-5 years of experience in international sales and marketing.
• Strong knowledge of CGT Single Use solutions.
• Excellent communication and client relationship management skills.
• Willingness to travel internationally.

Send your resume to: [email protected]

Roles and Responsibilities:

• Drive international sales growth for Single Use Bioprocessing solutions.
• Provide sales support and coordination for global sales teams.
• Conduct market research and track industry trends.
• Develop and maintain strong client relationships in key international markets.
• Identify and qualify international sales leads.
• Assist in pricing strategies, proposals, and RFP responses.
• Maintain accurate CRM records and manage the sales pipeline.
• Collaborate with regional sales teams to align market strategies.
• Prepare reports on sales performance, market trends, and customer feedback.
• Support participation in international trade shows, events, and conferences.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Business, Biotechnology, or Life Sciences.
• 2-5 years of experience in international sales and business development.
• Understanding of Single Use Bioprocessing solutions.
• Strong negotiation and communication skills.
• Willingness to travel internationally.

Send your resume to: [email protected]

Roles and Responsibilities:

• Develop and execute the product strategy for Drug Delivery Single Use Bags and Devices.
• Work closely with R&D, regulatory, and sales teams to ensure successful product
  development.
• Conduct market analysis to identify opportunities for new products and improvements.
• Define product specifications, pricing, and positioning.
• Manage product lifecycle, from conception to commercialization.
• Oversee regulatory compliance and quality standards.
• Develop sales training materials and marketing strategies.
• Build relationships with key industry experts and healthcare professionals.

Qualifications & Requirements:

• Bachelor’s/Master’s degree in Biomedical Engineering, Biotechnology, or Life Sciences.
• 5+ years of experience in product management within the medical device industry.
• Expertise in Drug Delivery Single Use Bags and Devices.
• Strong knowledge of ISO 13485, FDA, and MDR regulations.
• Excellent project management and leadership skills.

Send your resume to: [email protected]

Department: Product Development & Engineering

Job Summary:

We are looking for a visionary Product Manager to spearhead the development of innovative products for our Cell & Gene Therapy portfolio. This role will focus on designing and advancing novel therapeutic solutions, from initial concept through preclinical and early clinical stages, in close partnership with R&D, clinical, and manufacturing teams. The ideal candidate brings expertise in cell and gene therapy, a knack for translating scientific potential into viable products, and a drive to deliver life-changing treatments to patients.

Key Responsibilities:

• Product Concept Development: Identify opportunities for new cell and gene therapy products by analyzing scientific advancements, patient needs, and market gaps; define product concepts and initial specifications.
• Development Strategy: Create and manage the development roadmap for new therapies, prioritizing projects based on scientific feasibility, therapeutic impact, and business potential.
• Scientific Collaboration: Work hand-in-hand with R&D teams to design and refine cell and gene therapy products (e.g., CAR-T, gene editing, viral vectors), ensuring alignment with cutting-edge science.
• Process Integration: Partner with manufacturing and process development teams to embed scalability, reproducibility, and quality into product design during early development phases.
• Clinical Transition: Support the transition of products into clinical development by defining target indications, patient profiles, and early-stage trial requirements with clinical teams.
• Market Alignment: Conduct competitive analysis and stakeholder research (e.g., clinicians, payers) to ensure new products meet market demands and deliver differentiated value.
• Risk Management: Assess and mitigate risks related to technical challenges, regulatory hurdles, and development timelines, adapting plans to maintain progress.
• Cross-Functional Coordination: Act as the central point of contact across teams—R&D, regulatory, quality, and commercial—to drive cohesive product development efforts.
• Innovation Advocacy: Champion emerging technologies and methodologies (e.g., next-gen vectors, delivery systems) to enhance the cell and gene therapy product pipeline.

Qualifications:

• Education: MS, PhD, MBA in Lifesciences/Biotechnology, Bioengineering
• Experience:5+ years of product management or development experience in biotech/pharma, with at least 2 years directly involved in developing cell and/or gene therapy products.
• Technical Knowledge: In-depth understanding of cell and gene therapy development, including cellular engineering (e.g., T-cell therapies), gene editing (e.g., CRISPR), and vector design (e.g., AAV, lentivirus).

Skills:

• Strong ability to bridge scientific innovation with practical product outcomes.
• Experience managing complex, multi-disciplinary projects in a fast-paced environment.
• Excellent problem-solving and decision-making skills under uncertainty.
• Clear communication skills for technical and non-technical audiences.

Preferred: Background in oncology, rare diseases, or regenerative medicine; experience with CMC or early-stage regulatory submissions.

Key Competencies:

• Creative problem-solving and innovation
• Team-oriented leadership
• Adaptability to evolving science and priorities

Commitment to patient-centered outcomes

Send your resume to: [email protected]

Department: Product Development

Job Summary:

We are seeking an Automation Expert to join our Product Development team, focusing on leveraging automation to drive innovation in healthcare and pharmaceutical products. This role will design and implement automated systems to enhance the development process from concept through testing ensuring efficiency, precision, and compliance with industry standards. The ideal candidate brings technical expertise in automation and a strong preference for experience in biotechnological or medical environments, where they can accelerate the creation of impactful solutions.

Key Responsibilities:

• Automation Systems: Proficiency in designing and implementing automation solutions, including programmable logic controllers (PLCs), distributed control systems (DCS), and supervisory control and data acquisition (SCADA) systems.
• Control Systems: Knowledge of process control principles, including PID (Proportional-Integral-Derivative) controllers, feedback loops, and real-time monitoring.
  Robotics and Instrumentation: Experience with robotic systems, sensors, actuators, and other instrumentation used in bioprocess automation (e.g., bioreactors, fermenters).
• Bioprocess knowledge: Understanding of bioprocessing techniques such as fermentation, cell culture, downstream processing (e.g., purification, filtration), and scale-up from lab to production.Familiarity with biological systems, including microbial and mammalian cell cultures, and their integration with automated workflows.
• Knowledge of Good Manufacturing Practices (GMP) and regulatory standards (e.g., FDA, EMA) relevant to bioprocess environments
• Technology Selection: Research and recommend automation technologies tailored to biotechnology and medical product development needs.
• Cross-Functional Collaboration: Partner with R&D, quality assurance, and regulatory teams to align automation efforts with project timelines, quality standards, and compliance needs.
• Regulatory Compliance: Ensure automated systems adhere to healthcare and pharmaceutical standards (e.g., GMP, FDA 21 CFR Part 11), supporting validation and documentation efforts.
• Training & Support: Train team members on automation tools and foster their adoption to enhance productivity across the product development lifecycle.

Qualifications: 

Education: Bachelor’s degree in engineering (biomedical, mechanical, electrical, mechatronics, embedded systems), computer science, or a related field; advanced degree (MS, PhD) is a plus.

Experience: 4+ years of experience in automation engineering or a related role, with a focus on product development; preferred experience in healthcare and medical devices.

Technical Knowledge:

• Proficiency in programming languages such as Python, C++, or Java for developing automation scripts and control algorithms.
• Experience with software platforms like LabVIEW, MATLAB, or similar tools for simulation, data analysis, and system modeling.
• Experience with automation software (e.g., Siemens PCS 7, Rockwell Automation, DeltaV, etc.)
• Understanding of product development cycles in regulated environments, such as medical devices, diagnostics, or drug formulation.

Skills: 

• Strong problem-solving skills with an emphasis on process improvement.
• Hands-on experience designing and maintaining automated systems.
• Ability to work effectively in multidisciplinary teams with scientific and regulatory stakeholders.
• Excellent communication and documentation skills.

Preferred: 

• Experience with biotechnology/medical-specific automation, such as bioreactor control unit design.
• Familiarity with regulatory standards (e.g., FDA, EMA) and quality systems (e.g., ISO 13485, GxP).

Key Competencies: 

• Innovative thinking with a practical focus
• Precision and attention to regulatory detail
• Adaptability in a fast-evolving industry

Collaborative and proactive approach

Send your resume to: [email protected]