Scientist III - Technical Project Manager (HPLC, GMP)

About the position

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. 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.

Responsibilities

• Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry.
• Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols.
• Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.
• Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Independently performs and gives guidance on a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language according to SOP and GMPs.
• Independently troubleshoots equipment & instruments. Mentors' others in troubleshooting when applicable.
• Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Navigates the OOS/OOT/Atypical investigation process. Leads investigations and Root Cause Analysis and proposes CAPAs.
• Performs work assignments accurately, and in a timely and safe manner.
• Independently manages QC responsibilities.
• Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
• Coordinates laboratory activities of other team members in conjunction with the lab supervisor.
• Assists with the study design & protocol authoring. Leads data evaluation and study close-out.
• Independently completes QA facing tasks.
• Authors and leads more complex quality records.

Requirements

• 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 5+ years).
• Previous experience with HPLC or dissolution testing.
• Previous experience with quality investigations, technical writing (protocols and methods), and GMP regulations strongly preferred.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines.
• Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
• Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
• Exhibits strong written and oral communication skills.
• Displays exceptional time management and project management skills.
• Proven problem-solving and troubleshooting abilities.
• Ability to independently optimize analytical methods.
• Capable of cross-training on sample preparation techniques with another laboratory group.
• Thrives in a collaborative work environment.