Scientist
PharmaCROClinical ResearchRegulatory AffairsQuality Assuranceregulatory submissionfdacroinform
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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 Information Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Discover Impactful Work The DDS-AD-EC(US) is well equipped with modern instrumentation for structural characterization pharmaceuticals including various mass spectrometers, biophysical and analytical tools. This position will be in the DDS-AD-EC(US) Structural Analysis and Characterization (SA&C) group and will provide an opportunity to lead key activities required for progression of small and large molecule assets. A day in the Life Provide structural characterization of various API and protein therapeutics using vibrational spectroscopy. Characterize and identify foreign particulates by optical and digital microscopy, vibrational spectroscopy, and SEM-EDX. Characterize sub-visible and visible particulates by flow-imaging and LS techniques. Develop and implement various methods for structural characterization of coformulations and long-acting injectables (LAIs). Develop and implement various methods for sizing of various APIs in coformulations and LAIs. Develop and implement various methods for analysis and characterization of aggregate and particle formation in protein therapeutics. Provide high quality data and aid in drafting of sections for characterization reports and regulatory submissions. Represent line function in project teams and/or sub teams. Keys to Success Education and Experience A BS or MS degree in protein biochemistry, biophysics, pharmaceutical sciences or related fields 4-6 years of experience with an BS degree; 1-3 years with an MS degree 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. Preferred Qualifications API characterization using vibrational spectroscopy (VCD, IR and Raman). Experience in protein structure analysis such as secondary and tertiary structure, protein folding-unfolding, aggregates, and particles characterization and quantification using various spectroscopic and biophysical techniques including FTIR, CD, VCD, DSC, AUC, Fluorescence, SEC-MALS, particle analysis technologies (DLS, Micro-Flow Imaging, and HIAC). Elemental analysis using SEM-EDX. Proficient in and demonstrates highly effective oral and written communication skills. Team player and ability to work in a matrix environment. Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks. Physical Requirements / 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. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! 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.com 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 Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and sp
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