Scientist - Reviewer - Extractables and Leachables

1 month ago

Middleton, United States Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials 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 quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD Laboratory Services team has a direct impact 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 quality to deliver groundbreaking innovations

Discover Impactful Work:
Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

A day in the Life:

Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing. Works with multiple functional groups to meet business needs. Plans and organizes work with periodic supervision. Sets up and maintains analytical instrumentation. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines. Ensures QA findings are addressed appropriately. Aids and training to other team members. Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems. Communicates project status to project leader. Performs work assignments accurately, and in a timely and safe manner. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria 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 Success:
Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC Proficient in Microsoft Excel and Word Proven track record to interpret data by performing trend analysis Proven track record in technical writing skills Ability to independently optimize analytical methods Proven problem solving and troubleshooting abilities Good written and oral communication skills Time management and project management skills Ability to work in a collaborative work environment with a team

Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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