Manufacturing Associate II Job in New Jersey (NJ), Manufacturing, Immunology Career, Full Time Jobs in Hitachi Chemicals Advanced Therapeutic Solutions
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Manufacturing Associate II job in Allendale

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Hitachi Chemicals Advanced Therapeutic Solutions jobs
New Jersey (NJ), Allendale
Job Code:  HLS_Hit5
Employer:  Hitachi Chemicals Advanced Therapeutic Solutions
Category:  Manufacturing
Immunology
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  Allendale
Zip Code:  07401
Map: 
Allendale, NJ 07401, USA (Show on map)
09/10/2018

Description

Manufacturing Associate II

We are seeking highly motivated Manufacturing Associates who are interested in joining our fast-paced, dynamic environment.

The Manufacturing Associate MUST have the following to be considered:

B.S. or Associate's Degree with relevant experience

Experience with aseptic processing

Experience with GMP

Clean room experience

Knowledge of SOPs and good documentation

Under the supervision of the Associate Manager, the Manufacturing Associate 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/written communication skills and be flexible in their working hours as most of the positions start on 2nd shift. These positions are based in Allendale, NJ. 

Responsibilities:

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 environment, 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 progenitor 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. Performing investigations for deviations and completing deviations in a timely manner

Participate in the on-call program

Knowledge and Experience:

Bachelor’s or Associate's degree (with relevant experience) in a biologics or related field preferred

A minimum of 2 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 required

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

MUST be able to WORK 2nd SHIFT (Sunday-Thursday or Tuesday-Saturday)

Excellent organizational skills and attention to detail

Good verbal and written communication skills

Strong team-oriented interpersonal skills are essential

About Us

Hitachi Chemical Advanced Therapeutics Solutions, LLC (formerly PCT Cell Therapy Services, LLC), is an industry leader in contract development and manufacture of cell therapy products. HCATS works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, full scale cGMP/GLP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.

Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.

ref: (HLS_Hit5)
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