Senior Research Scientist - Oligoneucleotides

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Senior Research Scientist - Oligoneucleotides 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. Location/Division Specific InformationOur 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, including the development, validation, transfer, and lifecycle management of analytical methods for oligonucleotide therapeutics. 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: Provides technical leadership for oligonucleotide analytical development activities, including method development, validation, troubleshooting, and transfer in accordance with GMP and regulatory expectations. 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 analytical instrumentation (HPLC, UPLC, LCMS, GCMS) with particular expertise in oligonucleotide analysis. 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 projectrelated 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 & ExperienceEducated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry 10+ years’ relevant industry experience within a GMP laboratory Demonstrated industry experience supporting analytical development and GMP testing of oligonucleotide therapeutics is required 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, AbilitiesDemonstrated technical expertise in the analytical characterization of oligonucleotides using chromatographic and mass spectrometric techniques. 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. Apply today! http://jobs.thermofisher.comThermo 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 AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. 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We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant.