LIMS Administrator & Business Analyst (Hybrid)

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. 

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.  We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

The LIMS Business Analyst / Administrator is responsible for configuring, maintaining, and supporting the LIMS system to enable laboratory operations. This role builds and maintains Master Data, provides training and day‑to‑day user support, and collaborates with cross‑functional teams to implement improvements. The individual will serve as the site liaison to the technical LIMS team and translate laboratory workflows into LIMS processes. The role ensures the system supports compliant, efficient, and accurate data management for pharmaceutical operations.

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, stability program management and systems integration.
• Provide subject matter expertise on local and multi-site LIMS projects.
• Ensure system compliance with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
• Build and maintain static and variable master data within LIMS.
• Write and execute validation protocol test scripts, including validation of LIMS subroutines, analyses and other code-based functionality.
• Serve as primary contact for troubleshooting LIMS issues and work to resolve in a timely manner. Collaborates with IT, the LIMS Vendor, and System Administrators to troubleshoot / resolve application and end-user issues.
• Implement and manage Change Controls and CAPAs to address LIMS related corrections and ensure changes or CAPAs are completed within assigned time frame.
• Develop and maintain LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.
• Maintain critical data and metadata within LIMS (including but not limited to specifications, protocols, test methods, storage locations, equipment, utility testing schedules, and stability protocols), aka Master Data.
• Identify workflow gaps and implement solutions to improve efficiency.  
• Provide LIMS training to site personnel and support training efforts at other company locations as needed.
• As needed, provide coverage of Master Data building and end-user support for other company sites.

• Experience supporting and integrating lab applications in a regulated industry.
• Knowledge of 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.
• Strong understanding of LIMS and computer systems.
• Strong software troubleshooting experience.
• Strong understanding of laboratory processes, ideally in a FDA-regulated Pharma environment.

• Bachelor’s or Master's Degree in Life Sciences, Computer Science, or a related field.
• 3+ years of experience configuring and administering Laboratory Information Management Systems (LIMS).

Preferred Qualifications:

• 3+ years of laboratory experience in a GMP environment
• Experience building LIMS Master Data

Supervision Received: General Supervision
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: 0

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. 

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.