Jobs · OTHR · New Jersey

Cell and Gene Therapy Associate I

Minaris · Allendale, NJ · 2 mo ago
OTHRFull-time

About Minaris Advanced Therapies

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, Minaris turns breakthrough science into real-world treatments that change lives. A team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies.

Responsibilities

  • Manufacture Master and Working Cell Banks and perform activities within production facilities to support manufacture of Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).
  • Understand and apply aseptic technique concepts.
  • Operate and maintain equipment.
  • Perform solution and material preparation.
  • Participate in technical transfer activities and assist with execution of validation activities.
  • Receive and organize materials; identify and communicate material discrepancies.
  • Use support systems (e.g., LIMS).
  • Understand manufacturing processes and methods.
  • Collect and record scientific and process data per good documentation practices.
  • Follow compliance and regulatory requirements, cGMPs, and Standard Operating Procedures (SOPs).
  • Train others on basic SOPs, equipment, and unit operations.
  • Follow and execute Batch Records (BRs); revise and authorize simple BRs.
  • Participate in development of technical documents such as non-conforming events and deviations.
  • Suggest continuous improvement ideas and identify technical problems.
  • Participate in regulatory inspections and client audits.
  • Interact with groups that support manufacturing.
  • Cross-train in other areas and perform job functions across the site.
  • Perform other duties as assigned, including assisting in other departments.
  • Embody Minaris Advanced Therapies values and align daily actions with department and company culture.
  • Perform job-specific tasks in compliance with applicable regulations, international standards, and Minaris policies and SOPs.
  • Ensure thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.

Requirements

  • High School diploma and over 4 years of relevant experience or Associate’s/Bachelor’s degree (science preferred) with over 2 years of relevant or equivalent experience.
  • Ability to accurately perform arithmetic calculations including fractions, decimals, percentages, and basic algebraic and geometric calculations.
  • Clarity of vision at near and mid-ranges (less than 20 feet), depth perception, and ability to identify and distinguish colors.
  • Must be able to wear appropriate cleanroom attire (e.g., surgical masks) and all Personal Protective Equipment (PPE).
  • Works in production environment with exposure to latex, bleach, noise, equipment hazards (e.g., vacuum pumps, pressurized vessels), dangerous materials (e.g., chemicals, solvents, pathogens), freezer burns, allergens, and strong odors.
  • Proficient in oral and written communication skills; must be able to read, write, and understand English.
  • Proficient in Microsoft applications (Excel, Word, Outlook).
  • Holiday and shift work often required based on manufacturing schedule.
  • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
  • Regular and reliable attendance on a full-time basis.

Working Environment

  • Moderate noise level with numerous interruptions.
  • Fast-paced environment with the utmost responsibility for compliance with safety and health regulations.
  • Off-shift, weekend, and overtime duties may be required.
  • May travel by car and airplane to different locations, occasionally overnight.
  • Work environment includes office, lab (with biohazards/chemicals), and production settings with variable noise levels, temperatures, and inside/outside conditions.

Physical Requirements

  • Ability to stand, sit, or walk for long periods of time.
  • Ability to lift 40 lbs routinely.
  • Ability to crouch, bend, twist, and reach.
  • Ability to push/pull 40 lbs routinely, often, or occasionally.
  • Clarity of vision and ability to identify and distinguish colors.
  • Ability to perform activities with repetitive motions.
  • Ability to climb ladders, stairs, or scaffolding.
  • Ability to work in variable temperatures, high to freezing.
  • Must be able to wear appropriate PPE.

Pay

The estimated base salary range for this position based in the United States of America is included for all current openings. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of the variable cash programs (bonus or commission) as part of the compensation package.

Benefits

  • Comprehensive benefits package, including medical, vision, and dental insurance.
  • 401(k) retirement plan.
  • Paid time off.
  • Tuition assistance.

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