Senior Data Reviewer - Cell & Gene Therapy (GMP)

Work Schedule reputed company (Mon-Fri) Environmental Conditions Adherence to reputed company Good Manufacturing Practices (GMP) Safety Standards, Office This is a fully remote role supporting our GMP Lab in Middleton, WI. We welcome applicants from reputed company locations reputed company the US. Must be legally authorized to work in the reputed company without sponsorship. Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening. At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With reputed company conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. Our PPD® Laboratory Services team has a reputed company reputed company on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and reputed company to deliver groundbreaking innovations. Discover Impactful Work Performs reputed company laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry. Routinely acts as the project leader on multiple reputed company, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members. A day in the Life: • Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a reputed company of formulations and/or delivery systems. Understands and conforms to reputed company and protocols applicable to assigned tasks. Designs and drives experiments with minimal supervision. • Prepares study protocols, project status reports, final study reports and other project-reputed company technical documents. • Communicates data and technical issues to the reputed company and responds to reputed company needs and questions. • Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting reputed company and analytical problems. • Assists with reputed company systems and new equipment. • Assists in designing method validation or method transfer protocols and establish project timelines. • Reviews, interprets, and analyzes data for technical, reputed company and compliance to protocols, reputed company, SOPs, reputed company reputed company and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Keys to reputed company: Education • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification Experience • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years). • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities • Solid understanding and knowledge of general reputed company and separation science • Full understanding of laboratory requirements, PPD & reputed company SOPs, ICH guidelines, USP requirements and FDA guidance • Ability to apply reputed company reputed company and Word to reputed company tasks • Proficiency on technical operating systems • Proven problem solving and troubleshooting abilities • Effective oral and written communication skills • Proven ability in technical writing skills • Time management and project management skills • Ability to work in a reputed company work environment with reputed company • Proven problem solving and troubleshooting abilities • Ability to train junior staff • Prior GMP experience preferred Work Environment reputed company values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced e Apply tot his job Apply To this Job