R&D Senior Scientist – Chromatography Full-time

R&D Senior Scientist (Chromatography Services)

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.

This position will be based at our new bioanalytical laboratory in GoCo Health Innovation City which is due to open later this year. This lab will serve pharmaceutical and biotech customers with advanced laboratory services and leading-edge instrumentation across all phases of pharmaceutical development to help deliver life-changing medicines to patients worldwide and will provide comprehensive and full-service solutions, encompassing both small and large molecules, biomarkers and novel modalities.

The Senior Scientist will work in our R&D team and independently performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure compounds in a variety of formulations and/or biological matrices. They are responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. They coordinate laboratory activities of other team members in conjunction with the lab supervisor. They will assist with the study design & protocol authoring and lead data evaluation and study close-out.

A day in the life:

• 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/or biological matrices for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• 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 (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.

Keys to success:

• Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
• 5 + years previous experience that provides the knowledge, skills, and abilities to perform the job
• Subject matter expert in LCMS

Knowledge, skills, abilities:

• Experience within bioanalytics, chromatography services
• Technical capabilities with LCMS
• Intermediate knowledge of general chemistry and separation science
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
• Full knowledge of technical operating systems
• Ability to independently optimize analytical methods
• Ability to independently perform root cause analysis for method investigations
• Proven technical writing skills
• Proven problem solving and troubleshooting abilities
• Effective written and oral communication skills as well as presentation skills
• Time management and project management skills
• Ability to mentor others on technical operating systems
• Ability to independently review and understand project proposals/plans
• Ability to work in a collaborative work environment with a team

We offer competitive remuneration, annual incentive plan bonus, 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!

Physical requirements / work 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.