Sr Scientist – Assay Services – LCMS Full-time

Job Title

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.

Discover Impactful Work:

Independently performs 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. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. 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.

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:

Education:

• Bachelor's degree (life sciences preferred) or equivalent and relevant formal academic / vocational qualification.

Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or a Master's degree and three years of experience or a PhD.
• 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: Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines and ability to interpret and consider SOP and regulatory guidelines during study design activities. LCMS experience preferred. Ability to understand and independently apply GMPs and /or GLPs 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, facilitating effective communication within the team and with stakeholders. Displays exceptional time management and project management skills, ensuring efficient completion of tasks. Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues. Ability to independently optimize analytical methods. Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration. Thrives in a collaborative work environment, actively contributing to a cohesive and productive team. To demonstrate behaviors which align to the 4i Values of Thermo Fisher.

Working Conditions and Environment: Work is performed in an office environment, either in an on-site or remote capacity with exposure to electrical office equipment. Remote work environment should remain free of outside distractions. Occasional drives to site locations may be required.

Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Requires multiple periods of intense concentration. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.