Senior Analyst, Lab Systems
What We Do
Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state-of-the-art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.
To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.
The Senior Analyst, Lab Systems will play a key role in selection of vendors and systems, implementation, and maintenance of complex laboratory electronic systems. This role will lead in requirements gathering, user requirement specifications, configuration, solution design, design specifications writing, training, process improvement and support. Execute systems gap analysis, process mapping, road map creation to successful selection and implementation of new laboratory systems. Work with users extensively to identify solutions, provide user support for efficient and cost-effective operations.
- Serve as a project leader in the implementation Thermo Fisher SampleManager LIMS for QC, Manufacturing, and other areas as applicable.
- Lead gathering of user requirements, configurations, design specification and communicate with developers to ensure proper development of the Laboratory systems and other electronic systems used in GMP manufacturing.
- Describe workflow into software requirements, execute and review validation documents
- Set up and organize system specific processes
- Serve as the subject matter expert (SME) on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC and Manufacturing.
- Ensure Laboratory system is compliant with all relevant regulatory standards and support audits for LIMS specific topics
- Provide end user training to operate the system
- Support training and use of LIMS and other lab systems for each functional area
- Author, revise, implement, and manage LIMS and other lab systems related procedures for administrator and users
- Create and maintain data configurations for users and integration of the instruments to LIMS Partner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controls
- Lead, develop, and manage lab systems related change controls, NC, CAPAs Implement best practices on LIMS development, master data, reporting, and configurations
- Track and troubleshoot lab systems support program issues
- Collaborate closely with IT group and stakeholders in developing system infrastructure and database requirements
- Conduct risk assessments and champion continuous improvement
- Other duties as assigned by management.
Reports to: Associate Director of QC Analytics and Lab Operations
FLSA Status: exempt
Location: Arcadia, CA
Knowledge, Skills & Abilities:
- Knowledge of cGMP, ICH, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
- Prefer experience with SampleManager or other LIMS systems.
- Familiarity with routine analytical assays commonly performed on raw materials; knowledge of analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR is preferred
- Familiarity with translating batch records, test methods and stability protocols into technical requirements and configuring in a LIMS solution
- Experience in supporting sample plans, laboratory data and reports, data management and GxP compliance.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment
- Working knowledge of Deviations, Change Controls, and CAPAs
- Strong written and verbal communication skills
- Excellent interpersonal skills with experience dealing with all levels within the company
- Willingness to collaborate internally and with clients while following regulations
- Strong multi‐tasking ability in conjunction with proven organizational and record keeping skills
- Ability to organize assigned tasks in a fast-paced environment and monitor tasks / assignments that may impact timely completion with minimal supervision
- Ability to effectively manage multiple tasks and activities simultaneously
- Proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint, MS Project, MS Teams, Data Analysis Software, and other related applications
- Effective communication skills in small and large group settings
- Ability to lead complex topics in discussion and drive to resolutions
- Ability to work independently and/or part of an internal team or clients with minimal supervision
- Strong team player, able to meet deadlines and changing priorities
- Strong Organizational and Time Management Skills
- Understanding of cGMP regulations, preferably with Cell Therapy
- Strong knowledge of cGMP and ICH guidelines.
- Other regulatory agencies experiences preferred
- Solid understanding of 21CFR part 11 and GAMP5 Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards
Education & Professional Experience:
- Bachelor’s degree in Life Sciences, Engineering or Computer Science
- Minimum of 4 years of work experience with LIMS and other laboratory system in the Pharmaceutical, Life Sciences industry with cGMP, GLP.
- Experience with SampleManager preferred.
- Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis Tools
- Prior laboratory experience is a plus, but not required
- Must wear PPE due to safety requirements in designated lab areas
- May be required to support on-call after hours for lab systems support
- Must be able to read, write, and converse in English
Travel: Occasional. Less than 10%
Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk, and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling
- Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes
- Ability to work safely and effectively when working alone or working with others
This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.
Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.