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Job Details

GCP Bioanalysis Lab Operations Expert


Security Operations


Cambridge, Massachusetts, United States

GCP Bioanalysis Lab Operations Expert

Job ID


Mar 11, 2024


About the Role


About the role:

As a Good Clinical Practice (GCP) Bioanalytical Lab Operations Expert, 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 key responsibilities:

• Instrument fleet management: Oversee 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.

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

Role Requirements

Essential Requirements:

• A bachelor's in biochemistry, chemistry, pharmaceutical sciences, or a related field. Previous experience as a bioanalytical lab operations specialist in a GCP-regulated environment is highly preferred.

• Strong understanding of GCP guidelines, FDA regulations, and ICH guidelines related to sample management, laboratory documentation, and lab operations.

• 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.

Preferred Qualifications:

• Familiarity with GLP (Good Laboratory Practice)

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:

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

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 Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1[Register to View] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,000 - $195,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

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?

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Biomedical Research

Business Unit

Translational Medicine




Cambridge, MA

Company / Legal Entity


Functional Area

Research & Development

Job Type

Full Time

Employment Type


Shift Work