Laboratory Technician III - Validation on Demand

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
Supports Viral Clearance Validation on Demand Team in the performance of Down-Stream Purification for client processes. Performs assays such as Cell Culture, Cell-Based assays (BSL2 and BSL2 ) and equipment management according to an in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR), and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes test methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision.

Essential Functions and Responsibilities

• Conducts viral clearance assays and lab procedures as outlined in testing record and regulatory guidelines.
• Performs basic maintenance and inter-study changeover of AKTA FPLC systems.
• Operates in a team-based environment on the execution of nanofiltration and column chromatography steps in the performance of viral clearance studies.
• Accurately completes testing records and other required documentation according to Good Documentation Practices.
• Reports observations of ongoing tests to Study Director or Laboratory Supervisor/Manager.
• Communicates with Supervisor and other colleagues re: daily lab activities.
• Performs lab upkeep per GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Prepares reagents and restock labs with supplies.
• Maintains equipment, equipment logs, cleaning logs and initiate change controls.
• Aids in the training of new employees.
• Performs self and peer review of testing records to ensure documents are accurate and complete.
• Authors non-conforming events and laboratory investigations.
• Evaluates SOPs for accuracy and efficient operations and makes amendments as necessary.
• Understands the importance of the regulatory compliance and comprehension of the laboratory assays.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instruction on routine work and detailed instructions on new assignments.
• Contributes to the overall operations and to the achievement of departmental goals.
• Performs job specific tasks in compliance with applicable regulations, international standards, Minaris Advanced Therapies’ Policies and SOPs.
• 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.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

Knowledge, Skill & Ability

• Laboratory experience with emphasis on aseptic technique, cell biology and/or virology.
• Possesses a foundational knowledge of functional equipment used in down-stream purification operations.
• Knowledge of GDP, GLP and cGMP preferred
• Effective multi-tasking skill and time management required
• Ability to evaluate technical data and record data accurately and legibly
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of verbal and written communication
• Ability to work effectively as part of a team and exhibit effective interpersonal skills
• Ability to work under limited supervision and to handle problems of a difficult nature
• Proficient in oral and written communication skills
• Proficient in Microsoft (Excel, Word and Outlook)

Education & Experience

• High school diploma and over 6 years of relevant experience or
• Associates/Bachelor (science preferred) degree with over 3 years of relevant or equivalent experience
• At least 2 years of relevant experience in downstream purification, chromatography, nanofiltration or a combination thereof.
• AKTA FPLC and Unicorn Software experience is a plus.

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:

• Constantly work in a laboratory setting with biohazards and various chemicals
• Constantly identify and distinguish colors, such as on a pH strip
• Constantly wear appropriate PPE
• Constantly required to sit, and to reach to use computers and other office equipment
• Constantly stand for extended periods of time, up to four hours/time
• Constantly perform activities with repetitive motion
• Frequently required to lift up to 20 pounds
• Frequently required to climb ladders, stairs or scaffolding
• Constantly required to view objects at close and distant ranges with hand and eye coordination
• Frequently required to communicate with others

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.