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Job Requirements of Clinical Manufacturing Associate:
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Employment Type:
Contractor
-
Location:
Warren, NJ (Onsite)
Do you meet the requirements for this job?
Clinical Manufacturing Associate
Careers Integrated Resources Inc
Warren, NJ (Onsite)
Contractor
Pay Range: $36 - $40
100% onsite
Work Schedule as below:
This position is for one of the following shifts as determined by business need.
Friday-Tuesday 8:30 am- 5pm
Purpose And Product of Position:
Education and Experience:
Working conditions (us only):
100% onsite
Work Schedule as below:
This position is for one of the following shifts as determined by business need.
Friday-Tuesday 8:30 am- 5pm
Purpose And Product of Position:
- Manufacture human blood derived cell therapies per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment of a multi-product clinical facility under the supervision of Manufacturing Management. Clinical Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team environment according to an assigned schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
- This position is a member of the Cell Therapy Development and Operations (CTDO) organization.
- Required Competencies: Knowledge, Skills, and Abilities:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
- General knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Background to include an understanding of biology, chemistry, medical or clinical practices within industry
- Sufficient vision and hearing capability to work in job environment.
Education and Experience:
- Associates or Bachelors degree in related field is preferred
- Minimum of high school diploma and/or equivalent combination of education and experience is required
- 2-5 years of relevant GMP manufacturing experience. On the floor experience which demonstrates proficiency and compliant schedule adherence is highly desired. Extensive knowledge of SOPs and cGMPs and the knowhow to work within a regulatory environment. Demonstrates aptitude for engineering principles and manufacturing systems. Adaptable to a fast paced, complex and ever-changing business environment
- Duties and responsibilities:
- Production of human cell therapy lots through cell culture, harvest, and cryopreservation.
- Perform operations utilizing Aseptic technique
- Become fully trained and qualified in all aspects of assigned processes
- Develop a high level of technical knowledge of project(s)
- Weigh and measure in-process materials to ensure proper quantities are added/removed.
- Adhere to the production schedule ensuring on-time, internal production logistics.
- Record production data and information in a clear, concise, format according to proper GDPs.
- Work in a team based, cross-functional environment to complete production tasks required by schedule.
- Assist tech transfers in and out of the clinical facility.
- Motivated, team consciousness individuals are needed to fulfill job requirements.
- No direct reports will be assigned to this job role.
- Perform other tasks as assigned.
Working conditions (us only):
- Must have the ability and flexibility to work assigned shift (Day, Night, Weekends and/or Holidays).
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
- Must be able to work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
- Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Must be comfortable being exposed to human blood components.
- Must be able to be near strong magnets.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. During higher times of processing these activities may increase.
- Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
- Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
- Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
- Bend and Kneel - Required to bend or kneel several times a day.
- Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
- Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
- Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
- Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
- Due to the nature of clinical cell therapy manufacturing, mandatory overtime may be required.
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