GMP Jobs in Bengaluru

Associate Packaging Location: Bengaluru Employment Type: Full-Time Job Summary We are seeking a diligent Regulatory Compliance Team Lead to manage the qualification and compliance of packaging materials used in consumer products across the EMEA region. This role will focus on ensuring adherence to key EU and French regulations, coordinating testing and documentation, and collaborating closely with cross-functional teams to advance packaging compliance initiatives. Key Responsibilities Lead the qualification process for packaging materials used in consumer products, ensuring regulatory compliance across the EMEA region. Ensure packaging materials comply with relevant regulations including, but not limited to: EC 1223/2009 (Cosmetic Products Regulation) REACH Regulation (EC) No 1272/2008 French AGEC Law & Decree (including Article L. 5232) EU 2019/1021 (Persistent Organic Pollutants Regulation) EC 10/2011 (Food Contact Materials, if applicable) EU 528/2012 (Biocidal Products Regulation) Compliance with PFAS-related restrictions Conduct or oversee evaluations including: Packaging safety assessments (chemical compatibility, leaching/migration analysis) Stability and microbial integrity checks related to packaging Substance screening for SVHCs, POPs, phthalates, PFAS, and other restricted substances Review, validate, and manage supplier documentation such as Safety Data Sheets (SDS), Certificates of Compliance (CoC), Declarations of Conformity (DoC), migration test reports, and recyclability data. Collaborate effectively with cross-functional teams and external vendors/suppliers to ensure timely document collation and verification. Guide, mentor, and support junior team members involved in packaging compliance activities. Qualifications Bachelor s degree in Chemistry, Packaging Engineering, or a related field. Minimum of 2 3 years of experience in the life sciences industry, preferably within a packaging department. Strong understanding of packaging development and raw material chemistry. Excellent communication skills, demonstrating effective, timely, and proactive engagement with internal teams and external suppliers. Critical thinking ability to ask relevant questions, avoid redundant steps, and leverage past learnings to improve processes. Be part of a team driving compliance and innovation in consumer product packaging across the EMEA region. Collaborate with diverse experts and suppliers to ensure the highest standards of safety and regulatory adherence. Grow your career in a dynamic and evolving life sciences environment. Interested? Apply now to contribute your expertise to packaging compliance excellence! Qualification : Bachelors degree in Chemistry, Packaging Engineering, or a related field

Key Responsibilities: Cell Therapy Product Development: Lead the development of new cell therapy products, overseeing the validation process to ensure successful transition to the next stage of product development. Cell Culture Techniques: Apply extensive experience in different types of cell culture techniques, ensuring the optimal growth and maintenance of cells required for therapy products. Large-Scale Bioreactor Operations: Oversee the operation of large-scale bioreactors for biologicals, catering to both commercial and clinical requirements. Ensure that all aseptic operations are performed to the highest standards. Gene Transfer Methods: Utilize and manage both viral and non-viral methods of gene transfer, incorporating these techniques into cell therapy protocols. Equipment and Facility Maintenance: Maintain equipment and facilities in compliance with industry standards, ensuring the implementation of effective calibration, preventive maintenance, and validation programs. Documentation & Reporting: Prepare and review cGMP-compliant documentation, including SOPs, batch records, checklists, protocols, and reports. Ensure that all documentation is accurate and up to date for regulatory purposes. Team Leadership & Collaboration: Lead a team, providing critical technical and scientific recommendations, troubleshooting, and fostering innovation. Manage the day-to-day activities of team members while encouraging excellence in all aspects of work. Cross-Functional Collaboration: Work closely with cross-functional teams to advance the company s cell therapy pipeline, collaborating effectively in a matrixed team environment. Production Planning: Organize workflow by assigning responsibilities and preparing work schedules to ensure that production targets are met efficiently. Adherence to Project Timelines: Exhibit strict adherence to project timelines, ensuring that quality, safety, integrity, and accuracy are maintained throughout the development and production process. Sterile Practices & Compliance: Understand and enforce systems and processes related to sterile practices, safety protocols, work ethics, and environmental health standards. Key Skills: Cell Therapy Development: In-depth experience in the development of cell therapy products, with the ability to manage the entire development lifecycle from early-stage research through to product validation. Cell Culture Expertise: Expertise in cell culture techniques, both in small and large-scale systems, ensuring cell integrity and performance for clinical and commercial applications. Bioreactor & Aseptic Operations: Proficiency in large-scale bioreactor operations and aseptic techniques, ensuring contamination-free environments for cell and tissue production. Gene Transfer Methods: Hands-on experience in viral and non-viral gene transfer methods, including plasmid DNA transfections and viral vector-based techniques, critical for gene therapy applications. cGMP Documentation: Familiarity with preparing and reviewing cGMP documents, such as SOPs, protocols, and batch records, ensuring compliance with regulatory requirements. Team Management: Leadership skills to manage, guide, and motivate a team, ensuring high levels of collaboration, productivity, and excellence. Problem-Solving & Troubleshooting: Excellent troubleshooting skills, with the ability to innovate and provide technical solutions in the face of operational challenges. Cross-Functional Collaboration: Ability to collaborate across various teams and functions, working towards shared goals and the successful advancement of the cell therapy pipeline. Project & Time Management: Ability to manage multiple projects simultaneously, ensuring that work is completed on time while maintaining high quality and safety standards. Competencies: Leadership & Team Development: Strong leadership skills, with the ability to direct and motivate a team, fostering an environment of growth, innovation, and high performance. Communication Skills: Excellent verbal, written, and presentation skills, with experience in writing grants and research articles. Ability to effectively communicate with internal teams, external collaborators, and stakeholders. Attention to Detail: High attention to detail, ensuring accuracy and precision in all aspects of product development, documentation, and operational procedures. Problem-Solving & Innovation: Ability to troubleshoot and solve complex scientific problems, utilizing innovative approaches to overcome technical and operational challenges. Adaptability & Efficiency: Demonstrated ability to adapt to changing priorities and work in fast-paced, high-pressure environments while maintaining efficiency and meeting production targets. Quality & Safety Focus: Strong focus on maintaining high standards of safety, quality, and compliance throughout all phases of cell therapy development and production. Qualification : M.Sc. / MTech in Life Sciences with 12-18 years of experience in GMP Productioninvolving intense Cell Culture

Key Responsibilities: Primary Cells & Cell Lines: Work with primary cells and cell lines in the context of immunology and immuno-oncology, with experience in developing and validating cell and gene therapy products. Cell-Based Assay Development: Lead the development and execution of cell-based assays, including immunological and immuno-oncological assays, for assessing the efficacy and safety of therapeutic products. Molecular Biology Techniques: Apply molecular biology techniques such as PCR, qPCR, cloning, and real-time PCR to analyze cellular responses and validate product candidates. Flow Cytometry & Sorting: Utilize flow cytometry and sorting techniques for detailed cell characterization, analysis of immune responses, and product quality control. Cross-Functional Collaboration: Collaborate closely with internal teams across manufacturing, quality assurance, clinical development, and supply chain management to advance the cell therapy pipeline. External Collaboration: Engage and coordinate with external collaborators, including contract research organizations (CROs) and vendors, to ensure smooth development and execution of the cell therapy product lifecycle. Project Management: Exhibit strict adherence to project timelines, ensuring that all work is completed on time while maintaining the highest standards of accuracy, integrity, safety, and quality. SOP & Documentation: Prepare and review Standard Operating Procedures (SOPs), protocols, regulatory documents, and reports in alignment with program requirements and compliance guidelines. Sterile Practices & Compliance: Adhere to systems and processes related to sterile practices, safety protocols, work ethics, and environmental health and safety standards. Key Skills: Cell-Based Assays: Expertise in the development and execution of cell-based assays, especially in immunology and immuno-oncology contexts. Ability to assess immune responses and therapeutic efficacy. Immuno-Oncology Knowledge: Deep understanding of immuno-oncology, including cellular and molecular mechanisms of cancer immunity, and how to translate this knowledge into therapeutic strategies. Molecular Biology Techniques: Proficiency in molecular techniques like PCR, qPCR, cloning, and real-time PCR for gene expression analysis, assay development, and validation. Flow Cytometry & Sorting: Expertise in flow cytometry, sorting, and analysis of cellular subsets, with an understanding of how these techniques can be applied to immuno-oncology. Stable Cell Line Generation: Experience in generating and maintaining stable cell lines for therapeutic and assay development purposes. Cross-Functional Team Collaboration: Proven ability to effectively work and communicate within a highly matrixed team environment, working across various functional areas to achieve product development goals. Vendor Management: Strong experience in managing external vendors, including CROs and service providers, ensuring timely and quality execution of outsourced activities. Competencies: Immunological and Immuno-Oncological Expertise: In-depth knowledge of immunology and immuno-oncology, with practical application to cell therapy development. Molecular Biology: Expertise in PCR, qPCR, cloning, and other molecular techniques used for gene analysis and validation of cell therapy products. Effective Communication: Strong verbal and written communication skills, with the ability to present complex data clearly and interact effectively with both internal and external stakeholders. Collaboration & Teamwork: Excellent interpersonal skills, able to collaborate effectively within teams and across functions to drive the progress of the cell therapy pipeline. Project Management: Ability to adhere to timelines and manage multiple projects effectively, ensuring that deadlines are met while maintaining quality and compliance. Vendor & Stakeholder Management: Competency in managing relationships with external partners, ensuring that project goals and deliverables are met to the required standard. Qualification : M.Sc. / MTech in Biotechnology with 3-7 years of experience in GMP Production

Position: Quality Supervisor Quality Assurance Department: Quality Assurance Location: Bengaluru Role Overview: We are seeking a detail-oriented Quality Supervisor to conduct in-process and final inspections, ensuring products meet all required standards and specifications. The role involves inspecting raw materials, components, and finished goods, maintaining accurate records, and enforcing quality standards. Key Responsibilities: Perform in-process and final inspections based on drawings, standards, and specifications. Inspect raw materials, components, sub-assemblies, and finished products using precision measuring instruments. Maintain thorough records of inspections, test results, and non-conformance reports. Identify and segregate defective materials or products to prevent quality issues. Ensure compliance with ISO standards, customer-specific requirements, and internal quality guidelines. Qualifications: Diploma or B.Tech in relevant engineering or quality discipline. Strong attention to detail and understanding of quality assurance processes. Proficient in using measuring instruments and inspection tools. Ability to maintain accurate documentation and communicate quality issues effectively. Qualification : Diploma or B.Tech in relevant engineering or quality discipline.

Job Title: R&D Scientist Validation, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are looking for an R&D Scientist Validation to support the design, execution, and validation of new or improved services as part of our R&D strategic plan. This role will focus on validation services across the bioprocessing portfolio and involves working from early concept development through testing and final implementation. The position also contributes to lab and facility setup and ensures all necessary documentation is in place for successful service launches. Key Responsibilities: Provide technical support on innovation and development projects, collaborating with R&D project managers and cross-functional teams to ensure timely and efficient delivery. Assist in defining technical requirements based on customer and market needs to guide new service/product development. Help plan, assess risks, execute, and document technical studies at different stages of project development. Design and execute verification and validation studies to confirm alignment of service/product outputs with technical and marketing specifications. Support laboratory operations and ensure adherence to Environment, Health & Safety (EHS) standards and regulatory compliance. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field. Minimum of 3 years of experience supporting or leading technical projects within an R&D or bioprocessing environment. Strong problem-solving skills with a proactive, solution-oriented mindset and ability to work independently. Comfortable managing multiple projects simultaneously in a dynamic environment. Effective reporting and presentation skills, with the ability to tailor communication to various audiences. Preferred Experience: Familiarity with aseptic techniques and laboratory best practices. Working knowledge of Good Laboratory Practice (GLP) and scientific method principles. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field.

Key Responsibilities: QMS Documentation & Activities: Expertise in preparing and managing QMS (Quality Management System) documentation related to facility and engineering activities, including writing SOPs for lab instruments, equipment, and utilities, as well as preparing qualification documents (DQ, IQ, OQ, PQ), deviation handling, change control, risk assessment, CAPA, and commissioning documents. Cross-functional Collaboration: Work closely with both internal teams and external stakeholders to ensure the smooth implementation and execution of engineering maintenance activities. This includes document preparation, process review, implementation, and follow-ups with various functional teams and vendors. Facility Modification & Commissioning: Manage facility modification projects, including overseeing commissioning and qualifications documentation to ensure that changes are aligned with regulatory and operational standards. Lab Equipment Operations & Maintenance: Oversee the operation and maintenance of lab equipment, including CO2 incubators, deep freezers, autoclaves, biosafety cabinets, LAF, stability chambers, cooling incubators, lab centrifuges, water baths, hot air ovens, incubator shakers, water purification systems, bioreactors, cold rooms, and liquid nitrogen systems. Analytical Instrument Operations & Maintenance: Manage the operation and maintenance of analytical instruments such as flow cytometers, spectrophotometers, multimode microplate readers, chemical image systems, gel image systems, osmometers, pH & conductivity meters, weighing balances, and western blot instruments. Utility Equipment Maintenance: Manage the operation and maintenance of HVAC systems (including air handling units, chillers, cooling towers, and BMS monitoring systems), utility equipment such as transformers, DG sets, air compressors, nitrogen generators, and LT panels. Preventive Maintenance Planning: Prepare and review schedules for periodic maintenance of lab instruments, utility equipment, and facility infrastructure. Ensure that all maintenance activities are conducted timely and in accordance with operational needs. Corrective and Preventive Actions: Coordinate and oversee corrective and preventive actions related to observations during internal and external audits, ensuring continuous compliance with quality standards. Vendor and OEM Coordination: Serve as the primary point of contact for external vendors and OEM service providers for periodic preventive maintenance (PM), calibration activities, and addressing breakdown issues. Project & Facility Modification Support: Coordinate and support the execution, verification, and successful completion of new projects or facility modification activities. Safety and Sustainability: Ensure compliance with safety practices and procedures, sustainability programs, and hygiene maintenance standards across the facility. Key Skills: QMS Documentation: In-depth experience in writing and managing SOPs and qualification documents (DQ, IQ, OQ, PQ) for lab instruments and utility systems. Proficient in handling deviations, change controls, risk assessments, CAPA, and commissioning documentation. Lab Equipment Expertise: Strong knowledge in the operation and maintenance of various lab equipment, including incubators, freezers, autoclaves, biosafety cabinets, stability chambers, centrifuges, and water purification systems. Analytical Instruments Management: Expertise in handling and maintaining analytical instruments like flow cytometers, spectrophotometers, microplate readers, and various other lab-based instruments used for experiments and analysis. Utility Systems & HVAC Management: Strong knowledge of utility equipment management, including HVAC systems, transformers, DG sets, air compressors, and nitrogen generators. Preventive & Corrective Maintenance: Ability to plan, schedule, and execute preventive and corrective maintenance tasks for lab instruments and utility systems, ensuring minimal downtime. Vendor Management: Expertise in coordinating with external vendors and OEMs for service contracts, maintenance, calibration, and addressing equipment failures or breakdowns. Project Coordination: Ability to manage and execute facility modification projects, ensuring timely delivery and alignment with operational needs. Safety & Compliance: Sound knowledge of safety practices, hygiene, sustainability programs, and regulatory compliance within facility and equipment operations. Competencies: Attention to Detail: High level of attention to detail in handling documentation, operational processes, and safety practices. Problem Solving: Strong analytical skills to troubleshoot and resolve issues in equipment, systems, and processes. Interpersonal & Communication Skills: Excellent communication and interpersonal skills to effectively collaborate with internal teams, external vendors, and service providers. Project Management: Ability to manage projects efficiently, ensuring all modifications, installations, and maintenance activities are completed on time and within scope. Team Collaboration: Team-oriented mindset with a collaborative approach to work alongside internal departments and external contractors/service providers. Adaptability: Ability to adapt to changing priorities, work in dynamic environments, and manage multiple tasks simultaneously. Qualification : Diploma/BE in electrical and electronics, with QMS related certifications with 10+Years of experience.

Key Responsibilities: Operation & Maintenance of HVAC Systems: Oversee and maintain HVAC systems, including AHU (Air Handling Units), BMS (Building Management System), chillers, and other associated components. Project Management: Plan, schedule, coordinate, and monitor assigned engineering modification projects. Assess project requirements, calculate timelines, and sequence project elements for optimal efficiency. Infrastructure Planning & Design: Lead the planning and design of new infrastructure requirements, specifically lab spaces, ensuring compliance with operational needs. Prepare BOQs (Bills of Quantities) and issue tenders to potential vendors, in coordination with the Supply Chain Management (SCM) team. Coordination with Contractors: Manage relationships with external contractors and service providers for executing new construction works, lab renovations, and facility enhancements. Compliance & Safety: Ensure adherence to safety, health, and environmental policies. Work alongside various stakeholders to maintain compliance with GMP standards and guidelines related to infrastructure and equipment. Development of SOPs: Develop, implement, and maintain Standard Operating Procedures (SOPs) to ensure compliance with GMP (Good Manufacturing Practices) principles for facility and equipment operations. Training & Development: Train the contract maintenance team on site operations, ensuring that all maintenance activities comply with safety and operational standards. Facility Maintenance & Upkeep: Oversee the maintenance of electrical and safety fixtures like UPS & batteries, panels, lighting fixtures, fire detection systems, fire hydrants, public address systems, and lifts, with minimal disruption to daily operations. Preventive & Breakdown Maintenance: Plan and implement preventive, periodical, and breakdown servicing of machinery and equipment, ensuring minimal downtime and efficient operation of facilities. Key Skills: HVAC System Management: Expertise in managing the operation and maintenance of HVAC systems, including high and low-side components such as AHUs, chillers, and BMS. Project Management: Ability to manage engineering projects from planning to execution, ensuring alignment with schedules and budgets. Proficient in preparing project schedules and monitoring progress. Infrastructure Design & Planning: Strong knowledge of infrastructure planning, especially in lab design, and expertise in preparing BOQs and issuing tenders. Contractor Coordination: Skilled at liaising with contractors and service providers for construction, renovation, and facility upgrades. Safety & Compliance Knowledge: Understanding of safety, health, and environmental policies, and expertise in adhering to GMP standards for infrastructure and equipment. Maintenance Planning: Expertise in developing and executing maintenance schedules for electrical and safety systems, ensuring operational continuity and minimal disruptions. SOP Development: Proficient in developing and implementing SOPs related to equipment and facility management in compliance with industry standards. Training & Team Management: Ability to train and manage maintenance teams, ensuring high standards of operation and maintenance. Competencies: Presentation & Communication Skills: Strong verbal and written communication abilities, capable of presenting complex information clearly and effectively to different stakeholders. GMP Standards & Procedures: Knowledge of Good Manufacturing Practices (GMP) and familiarity with industry standards and regulatory requirements for facility management and equipment maintenance. Interpersonal Skills: Ability to interact effectively with various stakeholders, including contractors, vendors, and internal teams. Team Player: Collaborative mindset, working well within cross-functional teams and with external partners to achieve common goals. Project Schedule Preparation & Management: Competence in preparing, updating, and managing project schedules, ensuring deadlines and milestones are met. Qualification : Diploma/ITI 4- 6 years experience.