Senior Data Reviewer – Method Establishment Review, Small Molecule

This is a fully remote position, open to applicants in Wisconsin.

📋 Description

• Conduct intricate laboratory analyses of pharmaceutical products utilizing analytical instrumentation.

• Calculate, assess, and document data in compliance with PPD SOPs and industry standards.

• Serve as the project leader on various initiatives and collaborate with clients.

• Review and assess data, and prepare reports and protocols.

• Ensure scientific integrity of projects and communicate regulatory matters to senior team members.

• Independently execute method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds.

• Design and conduct experiments with minimal oversight.

• Create study protocols, project status reports, final study reports, and other technical documentation.

• Relay data and technical concerns to clients and address their inquiries.

• Mentor, train, and coordinate the laboratory activities of team members.

• Troubleshoot instrument and analytical challenges.

• Assist in quality systems and the integration of new equipment.

• Develop method validation or method transfer protocols and set project timelines.

• Review, interpret, and analyze data to ensure technical accuracy, quality, and compliance with protocols, methods, SOPs, client specifications, GMP, and GLP.

• Conduct self and peer reviews of data prior to submission to QA and delivery to clients.

⛳️ Requirements

• Must be legally authorized to work in the United States without the need for sponsorship.

• Must successfully complete a comprehensive background check, including drug screening.

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualifications.

• Over 5 years of prior experience or a combination of appropriate education, training, and/or directly related experience.

• Strong understanding and knowledge of general chemistry and separation science.

• Comprehensive knowledge of laboratory requirements, PPD and client SOPs, ICH guidelines, USP standards, and FDA regulations.

• Proficient in using Microsoft Excel and Word for task execution.

• Experienced with technical operating systems.

• Demonstrated problem-solving and troubleshooting skills.

• Strong oral and written communication abilities.

• Proven skills in technical writing.

• Effective time management and project management capabilities.

• Ability to work collaboratively within a team setting.

• Capability to train junior staff members.

• Able to convey, receive, and comprehend information and ideas with diverse groups of individuals.

• Able to stand and remain stationary for typical working hours.

• Capable of lifting and moving objects weighing up to 25 pounds.

• Willingness to work in non-traditional work environments.

• Proficient in utilizing and learning standard office equipment and technology.

• Potential exposure to hazardous elements, including infectious agents, in healthcare or laboratory settings.

• Able to perform effectively under pressure while prioritizing and managing multiple projects or tasks.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Resources available to support individual career aspirations.

• Opportunities for career development through impactful scientific work.

• Mentoring and training opportunities provided.

• Support for health and wellbeing.

• A healthy and balanced work environment.