Cell Therapy Specialist I

Job#: 1285570

Job Description:


The Cell Therapy Specialist I is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapy production and/or human cells cultivation.RESPONSIBILITIES?Produce clinical and commercial material that meets the site’s strategic objects and is compliant with cGMPs and safety regulations.?Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps?Collaborating with the Process Development and Manufacturing Sciences and Technology group to transfer new projects into GMP?Interact with internal and external stakeholders in the course of production duties?Identify, developand implement process improvements?Work with the manufacturing team to closedeviationand the closure of CAPAs?Recommend equipment and other supply purchases within the production areas?Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions?Workclosely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays?Work closely with various departments and aid other teams as necessary?Adhere to all cGMP manufacturing operations, documentation and safety guidelines?Post-production;prepare all GMP documentation for hierarchy approval.?Respect environmental health and safety (EHS) rules in working area.?Other duties as assigned.

EDUCATION/EXPERIENCE?B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.?0-2years of experience in biopharmaceutical based GMP manufacturing operations/Cell Therapy/Human Cell Cultivation.?Solid knowledge of FDA regulations and GMP systems.?Experience in cell culture and aseptic manipulations.?Experience in human cells cultivation preferred.?Demonstrated technical knowledge of bioreactors, disposable technology, chromatography, TFF, and aseptic processing a must.?Excellent oral and written communication skills. Strong technical writing ability required.


?Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.?Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasksPHYSICAL DEMANDS: While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.


While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate. A large amount of the work is completed in a cleanroom environment. While working in the area the gowning requirements are safety glasses, shoe covers, hood, gown, mask boots and gloves. Working conditions can include standing for long periods of time.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:

Webster, TX, US

Job Type:
Scientific and Clinical

Date Posted:
August 8, 2022