Operations Associate

Initial Therapeutics, Inc.; Raritan (NJ); On-site; USD 59,168 - 77,658; Full time

Benefits offered by this job

Medical Insurance

401(k) with match

Paid parental leave

Paid time off

Job summary

Legend Biotech in Raritan, NJ seeks an Operations Associate (2nd Shift) to support manufacturing of autologous CAR-T products in a GMP cleanroom. You will execute procedures, document data, and work with cross-functional teams to meet production schedules.

The role requires 3–5 years biotech or related experience, ability to handle hazardous materials, and strong attention to quality and compliance.

Qualifications

• HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent industry experience.
• Associates Degree required in Life Sciences or Manufacturing with 2-3 years related experience.
• Bachelor's Degree required in Life Sciences with 0-2 years biotech/pharmaceutical experience or equivalent industry experience.

Responsibilities

• Manufacture autologous CAR-T products in a CGMP cleanroom.
• Execute manufacturing or manufacturing-support processes per SOPs and batch records.
• Record production data accurately per GDP and maintain documentation.

Skills

Biotech manufacturing

cGMP knowledge

Equipment operation

Team collaboration

Education

HS Diploma

Associates Degree Life Sciences

Bachelor's Degree Life Sciences

Job description

Overview

Legend Biotech is hiring an Operations Associate (2nd Shift) as part of the Technical Operations team based in Raritan, NJ. This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.

Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise format according to Good Documentation Practices (GDP).
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
• Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing processes including appropriate documentation.
• Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
• Handle human derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOPs, logbooks and other GMP documents.
• Demonstrate training progression through assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Ensure materials are available for production.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
• Report to work on-time and according to the shift schedule.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate positive team-oriented approach in the daily execution of procedures.
• Promote and work within a team environment.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Support investigation efforts as required.
• Responsible for audit preparation and participation.

Qualifications / Requirements

• HS Diploma required with 3 – 5 years biotech/pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2 - 3 years of related experience // OR // Bachelor's Degree required in Life Sciences with 0 - 2 years biotech/pharmaceutical experience or equivalent industry experience
• Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Follow instructions.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools
• Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Mobility to independently transport between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Frequent communication with coworkers.
• Physical requirements: standing, walking, climbing, bending, stooping, and reaching with hands and arms.
• Ability to lift 25 lbs.
• Willingness to perform gowning procedures to work in manufacturing core.

Benefits and Pay

Pay Range (Base Pay): $59,168 - $77,658 USD. The company provides a base pay range that may vary based on experience, skills, qualifications, and geographic location.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance, 401(k) with company match, eight weeks of paid parental leave after three months, vacation, personal time, sick time, floating holidays, and eleven company holidays. Voluntary benefits include sections such as flexible spending accounts, health savings accounts, life and AD&D insurance, disability coverage, and voluntary add-ons. Optional commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs are offered to support employees.

Note: Benefits are offered to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

Legend Biotech is an equal employment opportunity employer. We do not discriminate based on race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or expression, sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable laws. Employment is at-will and may be terminated at any time with or without cause or notice. For information related to our privacy notice, please review: Legend Biotech Privacy Notice.