Senior Data Reviewer - Cell & Gene Therapy
About The Position
This is a fully remote role supporting Thermo Fisher Scientific’s GMP Lab in Middleton, Wisconsin. Applicants from anywhere in the United States are welcome. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. The Senior Data Reviewer performs complex laboratory analysis of pharmaceutical and biopharmaceutical products, uses analytical instrumentation, analyzes and records data in accordance with PPD standard operating procedures and industry requirements, and routinely leads multiple projects. The role includes client interaction, data review and evaluation, and preparation of reports and protocols. The position is responsible for the scientific conduct of projects and for communicating regulatory issues to senior-level team members. The role independently conducts method validations, method transfers, and analytical testing; designs and drives experiments with minimal supervision; prepares project documentation; communicates results and technical issues to clients; mentors and trains team members; assists with troubleshooting, quality systems, and new equipment; and reviews data for technical quality and compliance with applicable requirements before submission to QA and customers.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years; a combination of appropriate education, training, and/or directly related experience may be considered equivalent in some cases.
- Solid understanding of general chemistry and separation science.
- Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements, and FDA guidance.
- Ability to use Microsoft Excel and Word to perform tasks.
- Proficiency with technical operating systems.
- Problem-solving and troubleshooting abilities.
- Effective oral and written communication skills.
- Technical writing skills.
- Time-management and project-management skills.
- Ability to work collaboratively as part of a team.
- Ability to train junior staff.
- Legally authorized to work in the United States without sponsorship.
- Ability to pass a comprehensive background check, including drug screening.
- Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Ability to work upright and stationary and/or standing for typical working hours.
- Ability to lift and move objects up to 25 pounds.
- Ability to work in non-traditional work environments.
- Ability to use and learn standard office equipment and technology proficiently.
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Nice To Haves
- Prior GMP experience.
Responsibilities
- Independently perform method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds in various formulations and delivery systems.
- Follow methods and protocols applicable to assigned tasks and design and drive experiments with minimal supervision.
- Prepare study protocols, project status reports, final study reports, and other project-related technical documents.
- Communicate data and technical issues to clients and respond to client needs and questions.
- Mentor, train, and coordinate laboratory activities of other team members.
- Assist with troubleshooting instrument and analytical problems.
- Assist with quality systems and new equipment.
- Assist in designing method validation or method transfer protocols and establishing project timelines.
- Review, interpret, and analyze data for technical quality and compliance with protocols, methods, SOPs, client criteria, and GMP or GLP requirements.
- Perform self and peer review of data for accuracy and compliance with reporting requirements before submission to QA and issuance to customers.
- Lead multiple projects, interact with clients, and communicate regulatory issues to senior-level team members.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
