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Sr. Manufacturing Associate

Sunrise Systems, Inc., SUMMIT new jersey

This job is no longer available.

Sunrise System Inc. is currently looking for Sr. Manufacturing Associate - Liso Cell - CAR-T in Summit, NJ with one of our top client.

Job Title: Sr. Manufacturing Associate - Liso Cell - CAR-T

Location: Summit, NJ 07901

Duration: 6+ months possible to hire

Position Type: Hourly contract Position (W2 only)


Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday.

Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.


Start Date: 3/2. Possibility of offers with no interviews.



1. Purpose and Scope of Position:

·        Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management.

·        Manufacturing Associates adhere to regulatory requirements while performing job functions.

·        Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.


2. Required Competencies: Knowledge/ Skills, and Abilities:

·        Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique

·        Knowledge of cGMP/FDA regulated industry

·        Familiarity with Lean Manufacturing initiatives

·        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


3. Duties and Responsibilities:

·        Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.

·        Performs deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift.

·        Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.

·        Weighs and measures in-process materials to ensure proper quantities are added/removed.

·        Adheres to the production schedule ensuring on-time, internal production logistics.

·        Records production data and information in a clear, concise, format according to proper GDPs.

·        Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.

·        Works in a team based, cross-functional environment to complete production tasks required by shift schedule.

·        Motivated, team consciousness individuals are needed to fulfill job requirements.

·        Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead.

·        Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.

·        Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first time initiatives, etc.


4. Education and Experience:

·        Bachelor’s degree or Associate/ Medical Technical degree and 4 years of Manufacturing or Operations experience or High School diploma/GED and 6 years of Manufacturing or Operations experience.


5. Working Conditions:

·        Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.

·        Must be comfortable working with contained human blood components.

·        Physical dexterity sufficient to use computers and documentation.

·        Sufficient vision and hearing capability to work in job environment.

·        Ability to lift 25 pounds.

·        Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

·        Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.

·        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).

·        Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.

·        Routine exposure to human blood components.

·        Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.




Chenchukala Alwar | Recruiter

Direct: (732) 313 0243| Email: [email protected]


Satya | Delivery Manager

Direct: (732) 272 0262 |Email: [email protected]

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