Senior Scientist - LCMS Regulated Bioanalysis
Thermo Fisher Scientific

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.

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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.
  
• Ableto work upright and stationary and/or standingfor 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 technologywith 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.

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