Job Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We are seeking a motivated Lab Systems Administrator to join the Information Technology team in Monmouth Junction, NJ. This role is ideal for a professional with minimum 2 years experience administering and supporting laboratory computerized systems in a GxP regulated environment.

The candidate manages day-to-day system administration, implementation and support of Lab Systems and applications for the Quality Control, Method Validation and R&D working closely with analysts, instrument vendors and IT team members to keep systems compliant, reliable and available.

This role will leverage knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments, together with GAMP 5, 21 CFR Part 11, and Computer System Validation principles, to deliver governed and inspection-ready laboratory systems.

RESPONSIBILITIES

Lab Systems Administration and Support

• Manage Lab applications and systems including, but not limited to: Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments (Malvern instruments, GCMS, FTIR, UV-VIS, Density Meters, etc.)
• Collaborate with lab analysts and managers, instrument vendors, and other IT team members to implement, administer, and support GxP applications and systems in a controlled laboratory environment
• Support new system implementations and upgrades, assisting with design or configuration and validation (IQ/OQ/PQ) to ensure solutions meet business needs while adhering to IT policies, compliance standards, and GxP requirements, coordinating with vendors and escalating to management as needed

User Access and Data Management

• Maintain the GxP Systems Inventory and User Access Management, creating and maintaining roles and privileges, including activation and/or deactivation of users
• Support configuration management of validated systems, escalating changes to management for review and approval as needed
• Develop a strong understanding of Data Management and Data Integrity requirements as they relate to FDA regulations

Backup, Recovery and Data Integrity

• Perform data backup and restore procedures, including full system backups and restores of validated systems
• Support and guide data archiving processes to ensure archived data remains complete and retrievable
• Recover GxP systems when required and perform any other related activity assigned by IT Management, applying cGMP principles and following internal SOPs, work instructions (WIs), and regulatory requirements

Compliance, Quality and Continuous Improvement

• Conduct Periodic Reviews such as User Access Management, Systems Validation Reviews, and SOP Reviews to confirm computerized systems remain compliant with company procedures and regulatory agency requirements
• Assist with QMS processes within IT, especially change control impact assessments for GxP system changes, performing Root Cause Analysis and executing CAPAs
• Help identify opportunities to improve system usage, minimize manual effort and interventions where possible, and enable data integrations, escalating recommendations to management as needed
• Suggest alternate processes, procedures, and process automation pathways to streamline and increase the effectiveness and efficiency of IT operations, escalating proposals to management for consideration
• Collaborate with various stakeholders and support the implementation of best practices, escalating to management as needed
• Support regulatory, customer, and other such audits from the IT department

Requirements

REQUIRED QUALIFICATIONS

• Bachelor’s Degree in a technical field (i.e., Science, Engineering, Computer Science, IT or related field) and minimum 2 years relevant experience administering and supporting laboratory or computerized GxP systems experience in the pharmaceutical, biotechnology or other related highly regulated lab environment.

• Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Quality Management System principles.
• Excellent collaboration and communication skills, both written and verbal.
• Ability to manage competing priorities and flexibility to shift workload when needed.
• Working knowledge of Microsoft Office applications.
• A team player with the ability to work with people at all levels and diverse skill sets.

Preferred Skills

• Hands-on experience with Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments (Malvern instruments, GCMS, FTIR, Density Meters, etc.).
• Understanding of IT infrastructure related to Lab system (network) connectivity and security.
• Understanding of the interdependency between hardware and software/applications of Lab systems.

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office.

Anticipated salary range: $ 70,000 and $105,000 per year. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid