Manufacturing Associate II

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, we turn breakthrough science into real-world treatments that change lives. Our 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 and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Position Summary

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Essential Functions And Responsibilities

• Understands aseptic technique concepts
• Able to operate and maintain equipment
• Performs solution and material preparation
• Possesses basic technical knowledge and background
• Participates on and performs technical transfer activities
• Assists with the execution of validation activities
• Receives and organizes materials
• Identifies and communicates material discrepancies
• Uses some support systems (e.g. LIMS)
• Understands the concept of manufacturing processes and methods
• Collects and records scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
• Follows and executes Standard Operating Procedures (SOPs). Trains other on basic SOPs, equipment and unit operations
• Follows and executes Batch Records (BRs). Revises and authorizes simple BRs
• Participates in the development of technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests continuous improvement ideas and identifies technical problems
• Participates on regulatory inspections and client audits
• Interacts on a minimal basis with groups that support manufacturing
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under direct supervision
• Regular and reliable attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned and may be required to assist in other departments
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
  
  

Leadership Responsibility

• Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
• Identifies, recruits, and retains top-notch talent.
• Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
• Develop employees to meet both their career and organizational goals.
• Builds strong customer relationships and delivers customer-centric solutions.
• Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
• Comfortable working in ambiguous situations and adaptable to change.
• Must model the highest degree of moral and ethical behavior and maintain confidential information.
• High degree of autonomy and strong decision-making skills.
  
  

Knowledge, Skill & Ability

• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and 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 clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized
• vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
• Holiday and shift work often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
  
  

Education & Experience

• High School diploma and over 4 years of relevant experience or
• Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant or equivalent experience
  
  

Physical Requirements

The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While Performing The Duties The Employee Is

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to work in an office environment with minimal noise conditions
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/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 / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions
  
  

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.