Senior Scientist - Analytical Sciences

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

Designs, plans, leads, authors, executes, and interprets research and development studies, assay qualifications and test article validations. Acts as a Technical Reviewer and assay trainer, including partnering with Testing Operations during assay transfers. Leads and drives technical discussions, both internally and externally with clients. Interfaces with Business Development team regularly and authors custom quotes, as needed.

Essential Functions And Responsibilities

• Designs, plans, leads, executes, and interprets R&D and GMP studies.
• Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
• Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting.
• Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
• Writes research and development reports and ensures data are reported clearly and accurately.
• Excels in method troubleshooting and clearly communicates scientific knowledge both internally and externally.
• Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
• Designs and executes R&D studies under limited supervision.
• Drafts and executes qualification protocols, validation protocols, and other GMP methods under minimal supervision of supervisor or other technical lead. Author reports related to studies.
• Interfaces with business development team regularly, including authoring custom quotes / quote sections
• Thorough understanding of Good Manufacturing Practices
• Serves as technical reviewer and performs all required functions in LIMS.
• General lab housekeeping, ordering reagents and materials, initiate work orders, as needed.
• Responsible for ELPRO monitoring and response.
• Participates in assay transfers to Operations. Serves as trainer for inter- and intra-departmental staff.
• Initiate and track change controls
• Author and execute IQOQ, author equipment SOP, participate in CSV activities as needed.
• Investigates and responds to equipment out of tolerances (OOTs).
• Performs equipment preventative maintenance (PMs), as needed.
• Drafts test methods, standard operating procedures (SOPs), reagent protocols (RPs) and client protocols (CPs) under minimal supervision.
• Participates in client calls and face to face meetings as a subject matter expert.
• Ability to work in a team environment and independently, as required.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
• Attends scientific conferences / meetings, when feasible
• 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

• Strong virology knowledge and experience is required for this position.
• Experience with next generation sequencing is highly desirable.
• Experience with gene therapy vectors and/or gene and non-gene mediated cell therapies is a plus.
• Proven troubleshooting skills
• Ability to use judgement as dictated by the complexity of the situation
• Experience in a cGMP environment is highly desirable
• 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 very difficult nature
• Need to be able to read, write and understand English
• Proficient in oral and written communication skills
• Proficient in Microsoft (Excel, Word, Powerpoint and Outlook)
  
  

Education & Experience

• Bachelor's degree in Biological Sciences or science related field with 8 years of relevant, hands-on lab experience or
• Master's Degree in Biological Sciences with 6 years of relevant experience or
• PhD in Biological Sciences with 2 years or relevant 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 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 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
• Constantly required to view objects at close and distant ranges with hand and eye coordination
• Constantly required to communicate with others
• Frequently required to lift up to 20 pounds
  
  

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Special Working Conditions

• May be required to work Holidays and weekends and assist in shift work
• May be required to assist in other departments
• 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.

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.