Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionThermo 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 customers to make the world healthier, safer, and cleaner.Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate 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.Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader these are just a few career pathways available once your become a part of the Thermo Fisher's Clinical Research Group team.To learn how Thermo Fisher's Clinical Research Group can advance your career, apply now!A day in the Life:The primary purpose of this position is to 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.
Education and Experience:
Bachelor's degree in relevant life sciences program field
AND 4+ years of experience that provides the knowledge, skills, and abilities to perform the job
Preferred: 2+ years in CRO or GLP regulatory lab environment 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:
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.
Working Environment: Thermo Fisher Scientific Clinical Research Group 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 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.
As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Our 4i Values:Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.