FSP- Research Scientist
Collegeville, PA - USA
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Responsible for the regulatory and scientific conduct of development validation stability projects and/or other specialty technologies such as extractable/leachable studies. Performs troubleshooting on multiple analytical instrumentation and multiple detection techniques calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects interacts with clients on a weekly basis (or as needed) to provide updates reviews and evaluates data writes reports and protocols.
- Deliver responsive on-site oligonucleotide LCMS bioanalytical support scaled to the weekly study schedule.
- Maximize uptime and analytical readiness of in-scope LCMS and supporting laboratory instruments.
- Resolve routine and minor instrument issues at the point of need bridging coverage until vendor service attends site and reserving vendor engagements for repairs that exceed user-level scope.
- Maintain instrument software computer systems operating-system updates licensing and version control.
- Provide secondary small-molecule DMPK bioanalytical capacity when oligonucleotide and instrument demands allow.
- Deliver a visible collaborative presence that integrates with the customers scientific and laboratory support teams.
- Assay execution: Development and execution of oligonucleotide LCMS bioanalytical workflows including sample preparation extraction LCMS analysis and data review.
- Method support: Support of method transfer familiarization and routine troubleshooting for oligonucleotide assays including chromatographic and ion-pairing performance issues.
- Workflow flexibility: Ability to ramp quickly across multiple established oligonucleotide assay types and adjust to fill the weeks study demand.
- Data integrity: Review and handling of analytical data in line with the customers quality and compliance expectations.
- Routine maintenance: Preventive maintenance QC checks and consumable management for in-scope LCMS systems.
- First-line triage: Real-time diagnosis and resolution of minor issues at the bench for example power cycling basic troubleshooting and user-level repairs such as addressing a crashed LC needle.
- Hardware lifecycle: Coordination of hardware updates and component replacements as required.
- Escalation: Defined troubleshooting and escalation paths routing repairs that exceed user-level scope to the appropriate vendor service organization (e.g. SCIEX).
- Software maintenance: Management of instrument software updates patching and version control.
- Computer & operating system updates: Deployment of workstation operating system updates security patching and configuration changes on instrument-controlling computers coordinated with the customers IT function to avoid disruption to acquisition.
- License administration: Tracking and administration of instrument software licenses to maintain continuity of operation.
- Visible support: A consistent approachable presence within the laboratory areas supplemented by responsive communication via the customers collaboration tools.
- Vendor escort & coordination: Escorting and hosting instrument vendors on-site and coordinating with the customers analytical and laboratory support functions.
- Instrument readiness: Preparing instruments for relocation decommissioning or related activities.
- Assay execution: Support of established small-molecule DMPK bioanalytical workflows including sample preparation bioanalysis and data review.
- Workflow flexibility: Ability to ramp across multiple established small-molecule assay types and absorb overflow demand.
- Prioritization: Small-molecule work is scheduled around oligonucleotide bioanalysis and instrument support commitments and is agreed with the customer on a weekly basis.
- Familiarity with bioanalytical workflows sample preparation bioanalysis and data review with the ability to ramp quickly across multiple established assay types including small-molecule DMPK assays.
- For at least one of the two resources: demonstrable depth in LCMS instrument hardware maintenance and user-level repair together with management of instrument software and instrument-controlling computers updates patching version control operating system administration and license administration sufficient to resolve issues in-house and bridge coverage until vendor service engineers attend site.
- Relevant education or extensive directly relevant hands-on experience in lieu of formal education.
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 6 years).
- 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.
Thermo Fisher Scientific 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.
Required Experience:
IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more