A late-stage company headquartered in Pennsylvania with a focus on developing re-dosable gene therapies is looking to add four (4) manufacturing associates to its team (ideally contract to hire). Our client is hoping to bring in all four manufacturing associates at level 1 and would like for them to get started asap. The need for this additional support is being driven by a pivotal clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa. In this role you will be responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.
Education / Experience:Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
1+ year experience in mammalian cell culture in an academic or industrial laboratory
Knowledge of basic laboratory skills (aseptic technique, pipetting, etc.) are required.
Must be comfortable with performing tasks while fully gowned in an aseptic cleanroom environment.
Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
Mammalian cell biology experience is considered a plus.
Excellent verbal and written skills.
Good interpersonal communication skills.
Must be willing to work weekends, evenings, and holidays (as needed).
Responsibilities:Proficient in aseptic technique concepts.
Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
Perform aseptic processing including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
Perform media and reagent preparation duties as required.
Ability to operate and maintain equipment.
Perform equipment preventative maintenance and cleaning/disinfection as required.
Basic User trained on electronic support systems (i.e. BMRAM, MasterControl, etc.)
Perform, record and report various inventory tasks (i.e., consumables, media, cryovial, etc.)
Follows, revises, and executes SOPs and WBRs in accordance with cGMPs.
Collects and records scientific and process data per good documentation practices (GDPs).
Participates in quality event investigations by providing accurate information.
Assists with receipt and organization of materials.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Manages time well and multi-tasks to complete all assignments and responsibilities with supervisor's guidance.
Maintains a safe working environment for self and others, including work area cleanliness.
Monitors resources and enforces SOPs to ensure data integrity and compliance with industry.
Participates in process optimization and continuous improvement opportunities.
Computer Skills:Use of basic Microsoft applications efficiently.
Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventative Action initiatives, and Change Control procedures.
Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands and fingers to handle equipment or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.