Operations Associate, Sun-Wed, 1st Shift

BioSpace; Raritan (NJ); On-site; USD 57,445 - 75,396; Full time

Benefits offered by this job

Medical insurance

Dental benefits

401(k) match

Paid parental leave

Flexible spending accounts

Job summary

A leading biotechnology company is looking for an Operations Associate in Raritan, NJ. This role involves working in a cGMP cleanroom, producing CAR-T products, and requires strong problem-solving and communication skills. The ideal candidate should have a background in life sciences and relevant experience in the biotech industry. Competitive pay and a comprehensive benefits package are offered.

Qualifications

• High school diploma or equivalent with required years of experience.
• Strong ability to interpret written and oral instructions.
• Physical ability to perform various tasks including lifting 25 lb.

Responsibilities

• Production of autologous CAR-T products in a cGMP environment.
• Execute manufacturing processes according to SOPs.
• Collaborate in a cross-functional team to meet production goals.

Skills

Problem-solving skills

Strong communication skills

Basic math skills

Ability to interpret instructions

Education

High school diploma + 3–5 years in biotech/pharmaceutical

Associate’s degree in Life Sciences

Bachelor’s degree in Life Sciences

Tools

Manufacturing equipment

Laboratory equipment

Process Excellence Tools

Job description

Operations Associate, Sun-Wed, 1st Shift

Legend Biotech is a global biotechnology company dedicated to treating and curing life‑threatening diseases. Headquartered in Somerset, New Jersey, it develops advanced cell therapies across a diverse array of technology platforms including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.

This role is a member of the Technical Operations team based in Raritan, NJ.

Shift Schedule

Sunday–Wednesday, 1st Shift

Key Responsibilities

• Production of autologous CAR‑T products for clinical and commercial operation in a controlled cGMP cleanroom environment.
• Execute manufacturing or manufacturing‑support processes according to standard operating procedures and current curriculum.
• Manufacturing activities: cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform process unit operations according to SOPs and batch records, recording production data in clear, concise GDP format.
• Complete tasks on time in compliance with quality systems and cGMP requirements.
• Collaborate in a cross‑functional team to meet shift schedule goals.
• Aid in development of manufacturing processes and documentation.
• Drive continuous improvement initiatives leveraging observations and team input.
• Handle human‑derived materials in containment areas.
• Support schedule adjustments to meet production demands.
• Accurately complete documentation in SOPs, logbooks, and other GMP documents.
• Demonstrate training progression through assigned curriculum.
• Maintain working knowledge of basic cGMP requirements to ensure compliance.
• Wear appropriate PPE and maintain a clean, safe work environment.
• Proactively eliminate safety hazards and communicate unsafe behaviors.
• Ensure material availability for production.
• Perform work requiring exposure to biological materials and hazardous chemicals.
• Maintain distance visual acuity of at least 20/40 and color perception as specified.
• Support the ongoing production schedule by:
  • Reporting to work on time according to the shift schedule.
  • Performing other assigned duties.
  • Attending departmental and scheduled meetings.
  • Demonstrating positive team‑oriented communication skills.
  • Promoting a team environment.
  • Learning new skills, procedures, and processes as assigned by management.
  • Supporting investigation efforts as required.
  • Participating in audit preparation and audit participation.

Requirements

• High school diploma required with 3–5 years in biotech/pharmaceutical industry, or
• Associate’s degree in Life Sciences or Manufacturing with 2–3 years related experience, or
• Bachelor’s degree in Life Sciences with 0–2 years biotech/pharmaceutical experience.
• Strong ability to interpret written, oral, diagrammatic, or scheduled instructions.
• Problem‑solving skills in low‑standardization environments.
• Basic math skills: addition, subtraction, multiplication, division.
• Knowledge of and experience operating manufacturing, manufacturing‑support, and laboratory equipment.
• Familiarity with Process Excellence Tools.
• Knowledge of routine and non‑routine testing and sampling methods.
• Mobility required for independent transportation between various sites.
• Strong communication and interpersonal skills.
• Physical ability to stand, walk, climb, bend, stoop, reach, and lift 25 lb.
• Willingness to perform gowning procedures in manufacturing core.

Pay Range

$57,445 – $75,396 USD

Benefits

Legend Biotech offers a best‑in‑class benefits package including medical, dental, vision, 401(k) match, stock options, paid parental leave, paid time off, flexible spending accounts, disability coverage, legal assistance, and more.

EEO Statement

Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Employment is at‑will. The company maintains a drug‑free workplace.