Scientist - Chemistry Lab - Middleton, NS, Canada - ThermoFisher Scientific

Description

ThermoFisher Scientific Research Scientist - Large Molecule LCMS in Middleton , Wisconsin
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

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 guides.

As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.

Department:
Mass Spectrometry, GMP labs

Conducts and provides technical mentorship on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports.

Designs and implements method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and performs multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (GC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.

Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems.

Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
Assists business development group in technical sales and marketing, and presents posters at technical conferences.

Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).

Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to BS degree plus 7+ years' of experience or MS plus 6+ years' of experience, or PhD plus 4+ years' of experience).

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.

Intermediate knowledge of general chemistry and separation science
Intermediate knowledge of liquid chromatography mass spectrometry (LC-MS) and its application in large molecule analysis
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
Full knowledge of technical operating systems
Ability to independently perform root cause analysis for method investigations
Proven technical writing skills
Time management and project management skills
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Thermo Fisher Scientific values the health and wellbeing of our employees. 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.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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