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 QC LIMS Administrator has a unique opportunity to play a key role in development, configuration, validation, implementation and maintenance of the QC LIMS system and processes from ground up for a Cell and Gene therapy biotech startup. This role is a main point of contact for LIMS implementation and work in conjunction with Validation on the execution of testing scripts for IQ, OQ and PQ of implementation of new LIMS System. The QC LIMS Administrator will be responsible for leading and managing activities for LIMS system as it relates to various QC functional areas such as analytical, microbiology testing, Environmental Monitoring, raw materials, stability, and sample management. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations.
- Liaison with QA, QC, and IT to understand the user requirements and requests and communicate with developers to ensure proper development of the system Collaborate with stakeholders to develop requirements Describe workflow into software requirements, execute and review and validation documents Set up and organize system specific processes Become the subject matter expert on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC LIMS Support audits for LIMS specific topics Attend LIMS Administrator training and provide end user training to operate the system Support training and use of LIMS for each functional area Develop, review, and maintain LIMS related procedures for administrator and users Partner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controls Support QC LIMS related change controls, NC, CAPAs Support best practices on LIMS development, master data, reporting, and configurations Track and resolve LIMS support program issues Collaborate closely with IT group on the infrastructure and database requirements Participate in risk assessments Other duties as assigned by management.
Reports to: Associate Director of QC Analytical Operations
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
Education & Professional Experience:
- Bachelor’s degree in Life Sciences, Engineering or Computer Science Minimum of 4 years of work experience with LIMS 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 Strong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferred Solid understanding of 21CFR part 11 Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards 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 LIMS 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
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.