Sr Research Scientist – Pharma Full-time

Senior Research Scientist – Pharma

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

Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.

Discover Impactful Work:

The Senior Research Scientist – Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.

A day in the Life:

• Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
• Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
• Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
• Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
• Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
• Reviews protocols, project status reports, final study reports and other project-related technical documents.
• 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) 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 & Experience:

• Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
• 10+ years' relevant industry experience within a GMP laboratory

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:

• Effective written and oral communication skills as well as presentation skills
• Knowledge and application of industry best practices not yet represented by global regulatory requirements
• Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
• Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
• Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to independently review and understand project proposals/plans
• Proven ability in technical writing skills
• Ability to work in a collaborative work environment with a team
• Proven problem solving and troubleshooting abilities
• Ability to independently optimize analytical methods
• Time management and project management skills

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.

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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