About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Our Manufacturing Associate, CAR-T team manufactures human blood derived components per Batch Record and Standard Operating Procedures 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.
Shift Available
Sunday - Wednesday (with e/o Wednesday off), Onsite Day shift, 5 a.m. - 5:30 pm.
Responsibilities
Create inclusive culture that builds relationships with support groups
Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)
Executes transactions and process in all electronic systems and adheres to business continuity processes
Prioritizes safety of self and others
Reports safety events within 24 hours
Immediately escalates any/all issues that may impact compliance or safety of self and/or others
Complete documentation required by Source Governing Documents contemporaneously
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+
Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge
Train for proficiency in process systems and some supporting business systems
Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
Work within a control cleanroom environment and execute aseptic processing procedures (as assigned)
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
Continues to refine and improve manufacturing process technique to improve individual operational times
Verifies training completion prior to performing any GxP tasks
Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements
Additional Qualifications/Responsibilities
Knowledge & Skills
Knowledge of cGMP/FDA regulated industry
Basic mathematical skills
General understanding of cGMPs
Technical writing capability
Proficient in MS Office applications
Inventory control and/or management
Background to include an understanding of biology, chemistry, medical or clinical practices
Basic Requirements
A minimum high school diploma and/or equivalent is required. An associate or bachelor's degree in a related field is preferred
0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Working Conditions
Must be able to stand/walk for extended periods of time
Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection
Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
Work in areas that may have strong magnets
Must be able to work in a BSL2 / ML1 work environment handling human blood components
Work in areas with exposure to vapor phase liquid nitrogen
Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Summit West - NJ - US: $27.83 - $33.72per hour