Manufacturing Associate - Summit West, NJ

About the role

The Manufacturing Associate is responsible for producing human blood-derived components in a controlled, cGMP cleanroom environment in accordance with Standard Operating Procedures (SOPs) and regulatory requirements. This role operates within a collaborative, shift-based team structure and plays a critical part in ensuring the quality, safety, and timely delivery of life-changing therapies.

Responsibilities

• Set up and operate equipment to support blood component production through cell culture, harvest, and cryopreservation
• Apply aseptic technique for all applicable activities, including tube welding, connections, and transfers; aseptic qualification is required
• Weigh and measure in-process materials to ensure accurate quantities are added or removed
• Adequately adhere to the production schedule to support on-time, internal production logistics
• Record production data clearly and concisely in accordance with Good Documentation Practices (GDPs)
• Support deviation investigations and write-ups as needed
• Ensure on-time closure of assigned CAPAs within the designated shift
• Perform all tasks in alignment with site safety policies, quality systems, and GMP requirements
• Work in a team-based, cross-functional environment to fulfill shift production requirements
• Develop subject matter expertise (SME) and become a qualified trainer within a designated manufacturing function
• Maintain timely completion of all training assignments to uphold technical skills and process knowledge
• Contribute to continuous improvement projects, inspection readiness, and right-first-time initiatives, as assigned

Requirements

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or laboratory technique
• Familiarity with cGMP and FDA-regulated industry standards
• Strong technical writing capability
• Basic mathematical skills with a general understanding of cGMPs
• Proficiency in Microsoft Office applications
• Background in biology, chemistry, or medical/clinical practices preferred
• Prior experience in manufacturing and/or a scientific or engineering discipline

Qualifications

• Education LevelExperience Required
• We welcome candidates from a variety of educational backgrounds:
• Bachelor's Degree—Associate's / Medical Technical Degree
• 3+ years in Manufacturing Operations
• High School Diploma / GED
• 2+ years in Manufacturing or Operations

Knowledge, Skills & Abilities

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or laboratory technique
• Familiarity with cGMP and FDA-regulated industry standards
• Strong technical writing capability
• Basic mathematical skills with a general understanding of cGMPs
• Proficiency in Microsoft Office applications
• Background in biology, chemistry, or medical/clinical practices preferred
• Prior experience in manufacturing and/or a scientific or engineering discipline

Working Conditions

• Physical Requirements: Intermittent walking and sitting; ability to stand or sit for extended periods; ability to lift up to 25 lbs; sufficient vision, hearing, and physical dexterity to perform job functions
• Environment: Enclosed, restricted cleanroom with assigned pressure and temperature conditions; exposure to reagents, chemicals, sanitization agents, human blood components, and strong magnets
• PPE & Garments: Required use of cleanroom garments covering head, portions of the face, core body, and legs/feet in designated areas
• Restrictions: Makeup, gum, nail polish, and other potential microbial sources are prohibited in restricted areas; food and personal devices (e.g., cell phones, tablets) may be restricted in designated zones
• Comfort Level: Must be comfortable working with contained human blood components in a regulated environment

Compensation

Summit West - NJ - US: $27.83 - $33.72 per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.