FSP - Principal Scientist - Rapid Safety Methods

FSP - Principal Scientist - Rapid Safety Methods Thermo Fisher Scientific - 3.4 Boston, MA Job Details Full-time Estimated: $124K - $181K a year 8 hours ago Qualifications Biology CGMP Doctoral degree 11+ years GMP Master's degree Bachelor's degree Doctor of Philosophy Clinical trials Technical writing Senior level FDA regulations Full Job Description Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards 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. 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. Key responsibilities: Be a Subject Matter Expertise (SME) and to lead and participate in method development, validation/verification, transfer, and submission of the rapid safety methods, including qPCR mycoplasma, and BacT Sterility. Author and/or review technical documents, including method SOPs, study protocols and technical reports Author and/or review regulatory documents Provide SME assessment for deviations, CAPAs and change controls Participate in internal and external meetings Education and Experience: Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years') or equivalent combination of education, training, & experience. OR Master's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 10+ years) OR PhD (preferred) and previous experience that provides the knowledge, skills, and abilities to perform comparable to PhD plus 8+ years of work experience) Previous experience that provides the knowledge, skills, and abilities to perform the job 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 and Abilities: Hands-on experience and In-depth knowledge of qPCR mycoplasma , BacT Sterility , and other safety methods for the Biologics and Cell & Gene therapy (CGT) portfolio In-depth knowledge of testing, method verifications/validations, and product release specifications for the Safety methods In-depth knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept for the safety methods Excellent technical writing skills are essential Experience in Gene and Cell therapy is desirable Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency Partners effectively with internal and external functions Significant front room FDA/Inspectional experience on stability programs Working Environment: 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!