Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Thermo 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.

• 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 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.

• 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.

• 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.