FSP Senior Research Scientist-Dissolution Method Development

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description 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. This is an onsite position located in Collegeville, PA. Discover Impactful Work The Senior Research Scientist independently performs, oversees, and directs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical compounds for Long-Acting Injectables. Responsible for strategic planning, review, and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications. Provides strategic technical guidance and mentorship to the analytical team. Leads the development and implementation of new analytical methods and procedures. Acts as a primary point of contact for high-level client interactions and strategic project updates. A Day in the Life 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 instrumentation / technique / technology. • 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 by designing 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. • Leads in developing innovative technology and in evaluating and implementing new capabilities. • Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs. Leads advanced troubleshooting for various equipment & instruments. • Reviews protocols, compiles results from assignments and makes determination on acceptability per SOP acceptance criteria. Reviews overall study results and other project related technical documents. Keys to Success Previous experience in or non-GMP development phase laboratory Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years). Knowledge, Skills, Abilities Demonstrated knowledge of multiple analytical techniques with an emphasis on dissolution testing, Apparatus 1, 2, & 4 dissolution, non-compendial or novel dissolution 2-5 years' experience doing method development on dissolution Experience leading or contributing to dissolution method development Knowledge of pH, pKa, buffer systems, surfactants, solubility Performs and interprets analyses using techniques such as RP‑HPLC, SEC, UV‑Vis, DLS, and SCISSor, Knowledgeable about the drug formulation and development process Experienced in HPLC method development and understanding separation theory Has experience in testing of long acting parenterals/injectables (e.g., implants, injectable suspensions, in-situ-forming gels, etc.) or controlled/modified release formulations Able to contribute to innovative approaches to achieve project goals Proficient in Microsoft Excel and Word Experience with documenting using electronic laboratory notebooks Proven problem solving and troubleshooting abilities Good written and oral communication skills Time management and project management skills Self-starter but able to work in a collaborative team environment Demonstrated ability to mentor and coach junior staff to support professional growth and scientific excellence 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 50 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 typically found in healthcare or laboratory environments. Ability to perform successfully under pressure while prioritizing and managing multiple projects or activities This is an on-site based role with daily laboratory work