Manufacturing Associate II

Job Description

Job Description

Manufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours.

• Performs any and all required processing and manipulation required to produce and assess safe and efficacious products
• Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety
• Consistently produce a high level of documentation accuracy and clarity
• Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers
• Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices
• Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints
• Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation.
• Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures
• Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures
• Notifying Management of any deviation that may occur during processing or during equipment maintenance.
• Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions
• Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner
• Supports technology transfers into GMP manufacturing operations
• Participate in the on-call program

REQUIREMENTS

• BA/BS or Associate's Degree in a biologics or related field preferred
• 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing
• Current Medical Technologist license or equivalent is a plus
• Aseptic/cell processing and clean room experience preferred
• Demonstrates tact and courtesy in dealing with others
• Strong work ethic, methodical approach to new challenges
• GLP and GMP experience a plus
• Must be able to work independently and with minimal supervision
• Able to work in fast paced environment at times under pressure and with tight deadlines
• Excellent organizational skills and attention to detail
• Good verbal and written communication skills
• Strong team-oriented interpersonal skills are essential
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Ability to multi-task team is essential
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to work a flexible schedule that may include nights, weekends and/or holidays
• Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill)
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays and as required by the company

Working Environment May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.