Biologics Jobs in Bengaluru

Job Title: Senior R&D Scientist Downstream, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are seeking a Senior R&D Scientist Downstream to lead the technical development and execution of new or improved services aligned with our R&D strategic initiatives. This role focuses on downstream process development services and spans the full innovation cycle from defining specifications and designing solutions to validation and market launch support. You will work in close collaboration with R&D project managers and cross-functional teams to bring new bioprocess services to life. Key Responsibilities: Serve as the technical lead on innovation projects, working closely with R&D project managers and relevant departments to ensure successful project execution. Define and document technical specifications for new service and product developments based on customer and market requirements. Plan, execute, and report on technical studies, including risk assessments and experimental design, throughout various project stages. Lead and conduct verification and validation studies to ensure new services/products meet both technical and marketing requirements. Oversee lab setup and documentation in preparation for service commercialization. Ensure compliance with Environment, Health & Safety (EHS) standards and regulatory guidelines within laboratory operations. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific discipline. Minimum of 5 years of hands-on experience leading and delivering technical projects in a scientific or bioprocessing environment. Proven ability to work independently, troubleshoot complex problems, and think creatively to develop practical solutions. Experience managing multiple projects in parallel, with strong organizational and time-management skills. Excellent communication, reporting, and presentation skills, with the ability to tailor information to both technical and non-technical stakeholders. Preferred Experience: Familiarity with aseptic laboratory techniques. Working knowledge of Good Laboratory Practice (GLP). Experience in upstream or downstream biotechnology unit operations. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific discipline.

In this role the position will be based in India however will be working with teams in Japan and supporting the delivery of work in country. This would involve direct liaison with project teams, investigative sites and sponsors as might be required. All the communications would be expected to be done in Japanese and English- both written and verbal. Job Purpose: The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case. Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files. Key Accountabilities: Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan. Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) Photocopy, print distribute and retrieval of documents, as needed Maintain basic quality check procedures to ensure accurate maintenance of documents Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only) Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery) Payment/invoice processing including internal follow up with payment specialists in Finance Courier shipment of study document to the sites, vender and clients Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL Skills: N2, N3 fluency in Japanese (reading, writing, and speaking) Sound problem solving skills. Experience working in CROs or Life Sciences industry preferred. Support with document collection, customization, review for clinical trials being conducted in Japan. Liaise with sites & investigators on assigned projects to facilitate conduct and delivery. Work closely with project management teams on all assigned tasks. Ensure quality and compliance in all clinical research activities. Ability to interact professionally within a client organization. Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. Effective time management in order to meet study needs, team objectives, and department goals. Knowledge and Experience: Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience N2, N3 fluency in Japanese (reading, writing, and speaking) Qualification : Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

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