<p>Work Schedule</p> <p>Standard (Mon-Fri)</p> <p>Environmental Conditions</p> <p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)</p> <p>Job Description</p> <p>Job Title: Research Scientist - Biosafety</p> <p>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.</p> <p>Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.</p> <p>Summarized Purpose:</p> <p>Join our world-class team to lead and provide technical mentorship on PCR mycoplasma research and method development projects. This role will allow you to innovate in scientific method development, validation, and troubleshooting, ensuring flawless completion of technical protocols and reports. You will craft and implement method development/validation studies independently, offering critical insights and reviews of analytical data.</p> <p>Essential Functions:</p> <ul> <li>Independently perform analytical method development, optimization, and validation for pharmaceutical and biopharmaceutical compounds. </li><li>Craft and implement experiments independently, maintaining high standards for self and others. </li><li>Write, review, and critique study protocols, project status reports, and final study reports. </li><li>Lead analytical troubleshooting sessions, providing outstanding technical support. </li><li>Assist the business development group in technical sales and marketing, and present posters at technical conferences. </li><li>Lead the preparation and implementation of SOPs and quality systems, developing innovative technologies and evaluating new capabilities. </li><li>Review, interpret, and analyze data for quality and compliance with protocols, methods, SOPs, and GMP/GLP standards. </li><li>Perform self and peer reviews of data for accuracy and compliance before submission to QA and customers. </li></ul> <p>Qualifications - External</p> <p>Education and Experience:</p> <p>PhD with 4+ years of experience; OR MS degree with 7+ years of experience; OR BS degree with 8+ years of experience.</p> <p>Knowledge, Skills, Abilities</p> <ul> <li>Proficient in Microsoft Excel and Word </li><li>Proven ability to interpret data by performing trend analysis </li><li>Proven ability in technical writing skills </li><li>Ability to independently optimize analytical methods </li><li>Proven problem solving and troubleshooting abilities </li><li>Good written and oral communication skills </li><li>Time management and project management skills </li><li>Ability to work in a collaborative work environment with a team </li><li>Skilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences. </li><li>Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help. </li><li>Skilled at prioritization and navigating ambiguity with a positive demeanor. </li><li>Previous experience with GMP and TEM required </li></ul> <p>Work Environment</p> <p>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:</p> <ul> <li>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. </li><li>Able to work upright and stationary and/or standing for typical working hours. </li><li>Able to lift and move objects up to 25 pounds. </li><li>Able to work in non-traditional work environments. </li><li>Able to use and learn standard office equipment and technology with proficiency. </li><li>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. </li><li>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. </li></ul> <p>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</p>