Manufacturing Technician III

Position Summary:

The Manufacturing Technician III, 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.

Primary Responsibilities:

• 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.

Reports to: Senior Manager, Manufacturing

FLSA Status: Non-exempt

Location: Arcadia, CA

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.

Education & Professional Experience:

• Associates / Bachelors degree in Science related field preferred.
• 2-4 years of hands-on technical experience with Cell Therapy Manufacturing required
• Experience working with Cell lines either adherent or suspension
• Experience with multiple forms of Cell Processing equipment, i.e CliniMACS Prodigy, Sepax, Automated Cell Counting, Controlled Rate Freezers, etc.

Travel: None

Working Conditions:

• Must be able to work in setting with Biohazards and various Chemicals.
• Ability to wear personal protective equipment (PPE) including sterile gowning, safety glasses, lab coat, safety shoes and gloves.
• Must be able to work in environment with variable noise levels.
• Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, tablet device, calculator, and other cell processing equipment.
• Experience prolonged sitting, standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
• Must be able to perform activities with repetitive motions.
• Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
• Primary job functions are performed in a GMP cleanroom environment and secondary job functions are performed in a shared office setting
• Potential exposure to hazardous chemicals, gases, fumes, odors, mists, dusts, and other hazardous materials.
• Ability to work safely and effectively when working alone or working with others

Other Job Requirements:

• Must undergo vision examinations including but not limited to Snellen and Ishihara tests to assess, if any, physical accommodations to perform primary work duties and responsibilities upon hire

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.