FSP - Sr. Scientist - LC-MS/MS

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, youll 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.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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.

As a Sr. Scientis you will contribute to developing, validating, and implementing bioanalytical LC-MS/MS to quantify drugs and related compounds in biological samples to support drug development and regulatory filings.

• Perform method development, method validation, and sample analysis using LC-MS/MS to support non-clinical and clinical studies and embrace the power of new technologies in a GLP environment.
• Participate in software validation effort for regulated platforms (e.g. automated liquid handling equipment) per 21 CFR Part 11
• Independently troubleshoot LC-MS/MS assays when problems arise.
• Assist with method development and validation efforts for ligand binding assays for analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples
• Keep accurate and timely documentation of notebooks and study records per departmental guidelines and SOPs.
• Follow applicable company and departmental SOPs, safety, health authority guidance, GLPs, and other departmental guidelines.
• Keep current with required company and department trainings.
• Prepare or contributes to study reports following the departmental policies and procedures.
• Coordinate with necessary service engineers for instrument maintenance scheduling and handle service documentation for regulated equipment.
• Contribute to preparing and making scientific presentations at internal and external meetings.
• Maintain lab inventories and order lab supplies to ensure continuity of bioanalytical activities.

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• OR 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.

• Possess a solid understanding of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc.)
• Good basic analytical lab operational skills (pipettors, balances, digital literacy, etc).
• Excellent observation powers. Ability to work in a methodical and organized fashion. Ability to read and follow method or research protocols. Ability to write in a concise fashion in order to record all pertinent data in research book.
• Experience in biological sample handling
• Experience in automated liquid handlers for sample aliquoting and extraction in 96-well format.
• Proven technical expertise in extraction techniques (PPT, LLE, SPE, etc.), execution and troubleshooting of LC-MS/MS methods on at least one Sciex Triple Quad MS platform instrument
• Strong HPLC operational skills; basic theoretical understanding of HPLC - chromatographic modes (reversed phase, normal phase, etc.); column types, resolution parameters (void volume, retention factor, etc.), effect of column dimensions and flow rate on resolution, and gradient vs. isocratic elution
• Some understanding of SRM optimization: effect of mobile phase; in-source CID; mass resolution. Some experience in LIMS (e.g. Watson) for quantitation, data handling and archival
• Knowledge of GLP, 21 CFR Part 11, Regulatory Bioanalytical Guidance and general laboratory practices
• Knowledge and execution experience of immunoassays (LBA)
• Possess excellent communication and organizational skills in a cross-functional environment.

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 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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, 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!