Overview
Senior Research Scientist – Pharma at Thermo Fisher Scientific. The role 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. Provides technical and regulatory consulting to internal groups and clients and mentors senior staff. Acts as the technical project leader for multiple projects, interacts with clients to provide updates, reviews and evaluates data, writes reports and protocols.
Location
GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development; this role is based in our Pharma lab.
Responsibilities
* Independently plan the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
* Act as on-site Subject Matter Expert (SME) for various instrumentation/technique/technology and validation/method transfer.
* Evaluate available technical options to obtain desired quality of analytical results, cost efficiency, ease of production integration, and robustness.
* Demonstrate viability of in-house developed methods and client-transferred methods by designing validation experiments or other appropriate aspects of methodology or technology.
* Lead client discussions regarding project definitions, technical information exchanges and project status; provide recommendations on technical and regulatory issues.
* Review protocols, status reports, final study reports and other project-related technical documents.
* Lead in preparation and implementation of SOPs and quality systems, and develop innovative technology and evaluate new capabilities.
* Review, interpret, and analyze data for technical quality and GMP/GLP compliance; perform self and peer reviews of data prior to submission to QA and customers.
Keys to Success
* Education & Experience
Education & Experience
* Bachelor's degree in a relevant scientific area (e.g., chemistry, biochemistry)
* 10+ years of relevant industry experience within a GMP laboratory
In some cases an equivalency consisting of a combination of education, training and/or related experience may be considered.
Knowledge, Skills, Abilities
* Effective written and oral communication and presentation skills
* Knowledge and application of industry best practices not yet represented by global regulatory requirements
* Experience with method development, validation and associated regulatory and ICH requirements
* Strong chemistry and separation science foundation
* Ability to adapt to changing regulatory or industry standards and understand technical limitations
* Understanding of SOPs, ICH guidelines, USP requirements and FDA guidance
* Ability to review and understand project proposals/plans independently
* Proven technical writing ability
* Collaborative team player with strong problem-solving and troubleshooting skills
* Ability to independently optimize analytical methods
* Time and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. We are one team of 100,000+ colleagues, guided byIntegrity, Intensity, Innovation and Involvement.
EEO statement: 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: Job seekers requiring accommodations in the application process can contact the accessibility hotline at 1-855-471-2255 for assistance.
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