GCP Bioanalysis Lab Operations Expert

Summary

As a GCP Bioanalytical Lab Operations Specialist, you will oversee the equipment and sample management operations of a bioanalytical laboratory adhering to GCP guidelines. Your responsibilities include instrument fleet management, asset management, sample management, data management, computerized system validation, and continuous process improvement. You will collaborate with cross-functional teams and effectively communicate with internal and external stakeholders. A degree in a related field and experience in a GCP-regulated environment are preferred. Strong knowledge of GCP guidelines, FDA regulations, and ICH guidelines is required. Novartis offers a flexible working environment, a collaborative culture, and opportunities for growth and development. Competitive salaries and benefits provided.

About the Role

As a Good Clinical Practice (GCP) Bioanalytical Lab Operations Specialist, you will be responsible for the equipment and sample management operations of a bioanalytical laboratory that adheres to GCP guidelines. Your role will involve ensuring the highest standards of quality and compliance in the laboratory's operations, leading a team of sample managers, and effectively communicating with internal and external stakeholders.

Your main responsibilities will include but are not limited to:

• Instrument fleet management: be responsible for overseeing preventative maintenance/repairs and software updates in compliance with SOPs and regulatory requirements, and maintain logbooks in accordance with GCP standards. Write/edit/review SOPs for general instrument usage and maintenance.
• Asset management: responsible for purchasing CAPEX and low-value assets, in close collaboration with the lab scientists, facilities, and finance teams.
• Sample management: lead a team of sample managers, supervising the proper handling, labeling, storage, and disposal of clinical trial samples according to GCP guidelines, SOPs, and protocol requirements. Ensure the integrity and chain of custody of samples throughout their lifecycle.
• Data Management: Implement data management systems and ensure that data is properly recorded, stored, and backed up.
• Computerized System Validation and Management: Development and implementation of validation plan for computerized systems used in the bioanalytical lab, ensuring compliance with GCP guidelines and regulatory requirements, and managing system installation, configuration, training, data integrity, security, and system updates.
• Continual improvement: ongoing evaluation and improvement of laboratory processes, workflows, and efficiencies related to sample management and equipment operations. Implement automation and technology solutions to enhance productivity and data quality. Stay updated with industry trends, regulations, and advancements in bioanalytical sciences.
• Collaboration and communication: Collaborate with cross-functional teams, including lab staff, vendors, facilities, reconciliation specialists, and archivists to support bioanalytical activities in clinical trials. Communicate effectively with internal and external stakeholders. Foster a culture of collaboration, operational excellence, and continuous improvement within the team.

Essential requirements:

• Degree in biochemistry, chemistry, pharmaceutical sciences, or a related field with 7+ ( bachelor) or 5+ (master) years of experience. Previous experience as a bioanalytical lab operations specialist in a GCP-regulated environment is preferred.
• Strong understanding of GCP guidelines, FDA regulations, and ICH guidelines related to sample management, laboratory documentation, and lab operations. Familiarity with GLP (Good Laboratory Practice) is a plus.
• Laboratory operational excellence, and a strong desire to continuously improve efficiency, quality and automation.
• Familiarity with sample collection, labeling, storage, disposal, and archiving practices in a regulated laboratory environment. Understanding of sample chain of custody and documentation requirements.
• Ability to work independently and/or supervise a small team, and organize work across multiple projects to meet timelines.
• Eagerness to take on additional responsibilities when required; flexibility to adapt to changing priorities and strategies.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Biomedical Research

Business Unit
Pharma Research

Location
Switzerland

Site
Basel (City)

Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No