What We Do
Theragent, Inc. 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.
Job Title: Senior Manufacturing Technician, Cell Therapy
Reports To: Senior Manager, Manufacturing
Location: 11750 Goldring Road, Arcadia, CA 91006
The Senior Manufacturing Technician, Cell Therapy position is responsible for the hands-on manufacturing of clinical cell therapy product according to current Good Manufacturing Practices (cGMPs) and procedures. The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process Development.
- Participates in the hands-on manufacture of cell therapy products, using state-of-the-art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, M1 Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and CellDrop).
- Follows and executes batch records and standard operation procedures.
- Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.
- Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.
- Performs delegated work assignments in a timely and complete manner.
- Supports Process Development and Manufacturing Sciences, as needed.
- Authors and maintains controlled documents including but not limited to SOPs, forms and batch records.
- Assists with deviation investigations and implementing CAPAs.
- Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.
- Maintains manufacturing facility in a 5S and inspection-ready state.
- Cross trains in other areas including Vector Manufacturing, Manufacturing Sciences, Process Development, QC and QA to perform additional job functions, as necessary.
- Trains and leads other Technician I on all processes and equipment functionality.
- Responsible for assisting with startup activities in area of responsibility.
- Assists in commissioning & qualification of production equipment.
- Assists in the review & creation of operation documents by providing input to technical composition of documents.
- Operates on the manufacturing floor in accordance with cGMP's and standard operating procedures.
- Prepares equipment for manufacturing operations and monitors equipment to ensure process specifications are met.
- Uses and maintains bench top equipment in accordance with relevant procedures.
- Effectively demonstrates understanding of cGMPs & applies to specific responsibilities.
- Follows accurate oral & written procedures when operating production equipment & performing processing steps.
- Maintains orderliness of process area.
- Practices safe work habits and adheres to Resilience’s safety procedures and guidelines.
- Assists in training of new and junior staff.
- Utilizes manufacturing knowledge to improve process operations and affect positive change.
- Escalates issues related to product and safety to senior staff.
- Must be able to work in setting with Biohazards and various Chemicals.
- Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE).
- Must be able to work in environment with variable noise levels.
- Ability to stand, sit, and walk for long periods of time. Ability to lift, push and pull 40 lbs. routinely. Ability to crouch, bend, twist, and reach.
- Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
- Must be able to perform activities with repetitive motions.
- Associates/Bachelor’s (science preferred) degree with 4+ years in cGMP manufacturing environment or Bachelor’s degree and 3+ years experience.
Knowledge, Skills & Abilities
- Excellent oral and written communication skills. Strong organization skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently. Good attention to detail and ability to follow written procedures. Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines.
- Reliable Adaptable Willingness to learn Will occasionally require weekend, late evening, and overtime work to support scheduled and unscheduled cell therapy manufacturing operations.
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.