Manufacturing Associate I

Job Description

Job Description

"Bridging Innovation to Cure"Developing and manufacturing your cell therapies from benchtop to bedside"JOB SUMMARYCellipont Bioservices is growing, and we are looking for a Manufacturing Associate I who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The Manufacturing Associate I is an entry level role and will be responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment. The Manufacturing Associate I is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products.THE ROLEAssists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicableEnsures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standardsConduct ancillary activities in support of processing functions, e.g. lab and equipment cleaning and maintenance, inventory management and stocking, preparing shipping/packaging materialsMaintains a strong culture of safety, quality, accountability, cost efficiency, on time delivery and customer serviceEnsures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings to the attention of a supervisor.Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trialsInform Supervisor of equipment needs and supplies required to avoid interruption in processes tagging out/equipment for recalibration.Routine monitoring and troubleshooting of equipment, with appropriate escalation if necessary.Other tasks as assignedTHE CANDIDATEBachelors Degree in Life Sciences preferred, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering.0-1+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment0-1+ years of direct experience working within manufacturing operations and leading by example; capable of helping to train other manufacturing techniciansUnderstanding of GMP and GDP requirementsExcellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlinesAble to demonstrate willingness to problem solve and/or diagnose process/product/equipment problemsExcellent oral and written communication skills. Strong technical writing ability requiredMust be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environmentMust be proficient in Microsoft Word and Excel. Experience in Microsoft Projects, Visio, and preferredAbility to work flexible hours and inconsistent schedules as necessary to meet production demands and timelinesPHYSICAL DEMANDSWhile performing the duties of this job, the employee is frequently required to stand and/or sit for extended periods. The employee is occasionally required to walk; have high levels of hand/finger dexterity; climb or balance and stoop, kneel, crouch, or crawl.The employee must occasionally lift and/or move up to 25 poundsWORK ENVIRONMENTWhile performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; biological materials or caustic cleaning chemicals; strong magnets; and sensitive calibrated equipment.Noise level in the work environment is usually moderateA marginal amount of the work is completed in a clean-room environment; employees may be expected to work in clean room conditions for up to 4-6 hours at a time.While working in the area the gowning requirements are safety goggles, shoe covers, hood, gown, mask, boots and gloves.Working conditions can include standing for long periods of time.POSITION BENEFITSOpportunities for career growth within an expanding teamDefined career path and annual performance review & feedback processCross-functional exposure to other areas of within the organizationRobust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members401K strong employer matchTuition ReimbursementEmployee Referral BonusesFlexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidaysGain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm RepresentativesCellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.