Scientist - GMP, Chemistry

Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description 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 customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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. As a Scientist, you provide technical support for Release and Stability Laboratory (RSL) department supporting method validations, investigations, reference standard and external testing. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the customer's vision and values. Additional key responsibilities for the role on site at a major pharmaceutical company: Oversee RSL method validations and/or method transfer activities to support project timelines. Serve as RSL representative in cross-functional, cross-departmental working teams Perform data review of method validations to meet project timelines May support in the managing of RSL change controls, deviations, and investigations. Assist in troubleshooting of analytical methods when necessary Authors and reviews SOPs, analytical methods, protocols and reports May support external testing oversight for incoming materials Assists in reference standard qualification/COA generation Participates in compliance related teams working towards the goal of continuous improvement. Education and Experience: Bachelor's degree or Master's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years with bachelors or 0-2 years with masters). Preferred Experience: Previous industry experience with a least 1 year of method validation/transfer experience Knowledge, Skills and Abilities: Solid understanding and knowledge of general chemistry Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections. Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements Knowledge of Nuvolo, Veeva, and QDOCS is a plus 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 Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff Working Environment: 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. 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 specific details about your required accommodation to support you during the job application process.

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