Analytical Sciences - Testing - Scientist

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

Performs basic to high complexity biosafety and analytical assays according to and in compliance with current Good Manufacturing Practices (cGMP) and/or Current Good Laboratory Practice (cGLP), 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. Performs daily work activities with minimal supervision.

Essential Functions and Responsibilities 

• Conduct basic to high complexity assays and lab procedures as outlined in testing record and regulatory guidelines. 
• Accurately complete testing records and other required documentation following Good Documentation Practices 
• Performs assays using appropriate laboratory techniques 
• Perform data analysis 
• Reports observations of ongoing tests to a Scientist and/or Laboratory Manager  Communicates daily lab activities with supervisor and other colleagues 
• Prepare reagents and re-stock labs with supplies 
• Maintaining equipment’s cleaning logs 
• Maintain equipment logs 
• Act as a mentor to the analysts 
• Aids in the training of new employees 
• Perform classroom trainings 
• Serve as an assay trainer or departmental training coordinator. 
• Work with supervisors to schedule daily activities 
• Can have direct or indirect reports 
• Performs lab upkeep per cGMP, CFR and/or PTC guidelines and SOPs. 
• Performs self and peer review of testing records. Perform Technical Review of executed testing records to ensure documents are accurate and complete. 
• Authors quality events as needed. 
• Author Test Methods, Client Protocols, SOPs, Validation/Qualification protocols, etc.
• Author Change Requests as needed 
• Act as a liaison for client meetings 
• Prepare and/or submit samples for shipment in accordance with established procedures, as needed 
• Support client audits and regulatory inspections, as applicable. 
• 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 on new assignments.  Designs, plans, and executes R&D studies under very limited supervision 
• Writes research and development reports and ensures data are reported clearly and accurately 
• Contributes to the overall operations and to the achievement of departmental goals.
• May be required to assist other departments. Collaborate with other departments on projects 
• 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. 
• Other duties as assigned.

Knowledge, Skills & Ability 

• Laboratory experience 
• Technical and Scientific knowledge of biosafety and analytical assays 
• Knowledge of GDP, and cGMP and/or cGLP 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 

• Bachelors’ degree in Biological Sciences, or other science related major, with 6+ years of relevant or equivalent experience OR 
• Master’s degree with major in Biological Sciences, or other science related major, with 4+ years of relevant or equivalent experience

Quality Requirements 

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work. 
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Working Environment

Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Physical Requirements

The physical and mental demands described below are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. While performing the duties of this role, the employee is required to: 

• Constantly work in a laboratory environment in proximity to biological materials, chemicals, and technical equipment. 
• Constantly wear appropriate personal protective equipment (PPE) in accordance with safety and regulatory requirements. 
• Constantly distinguish colors accurately (e.g., interpreting pH strips, test indicators, or assay results). 
• Constantly sit and reach while operating computers and other standard office equipment. 
• Constantly stand for extended periods, up to four hours at a time. 
• Constantly perform tasks involving repetitive motions, including hand and wrist movements. 
• Frequently lift and/or move materials weighing up to 20 pounds. 
• Constantly use close and distance vision, depth perception, and hand–eye coordination to perform detailed analytical work.
• Frequently communicate verbally and in writing with colleagues and cross-functional partners. 

This position requires the ability to work safely in a laboratory setting with potential biological, chemical, ergonomic, and physical hazards while adhering to all safety policies and procedures.

Frequency Definitions: 

• Occasionally – up to 1/3 of the workday 
• Frequently – 1/3 to 2/3 of the workday 
• Constantly – 2/3 or more of the workday 

Special Working Conditions 

• This position may be required to travel up to 25%, which may include local and occasional overnight travel based on business needs. 
• May be required to work Holidays and weekends and assist in shift work 
• May be required to work overtime

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.