FSP- Research Scientist
Schedule
Standard (Mon‑Fri) – fully onsite in Collegeville, PA.
Environmental Conditions
Office setting; fully onsite.
About the role
Thermo Fisher Scientific’s PPD® Laboratory Services team delivers regulatory and scientific conduct of development, validation, stability projects, and specialty technologies such as extractable/leachable studies. The role involves troubleshooting multiple analytical instruments, interpreting data, and adhering to PPD SOPs while acting as the technical project leader for multiple projects, interacting with clients, and preparing reports and protocols. The position provides dedicated on‑site oligonucleotide LC‑MS bioanalytical capacity to the customer’s DMPK group, supported by instrument field support and secondary small‑molecule DMPK bioanalytical capacity when demand allows.
Responsibilities
- Conduct regulatory and scientific development, validation, and stability projects, including specialty technologies.
- Troubleshoot multiple analytical instrumentation and detection techniques; calculate, interpret, and record data per SOPs.
- Act as technical project leader for multiple projects; provide weekly client updates, review and evaluate data, and author reports and protocols.
- Deliver responsive, on‑site oligonucleotide LC‑MS bioanalytical support scaled to weekly study schedules.
- Maintain uptime and analytical readiness of in‑scope LC‑MS and supporting laboratory instruments.
- Resolve routine and minor instrument issues at the bench, bridging coverage until vendor service engineers attend.
- Perform preventive maintenance, QC checks, and consumable management for LC‑MS systems.
- Coordinate hardware updates, component replacements, and escalation of issues beyond user‑level scope.
- Manage instrument software updates, patching, version control, and license administration.
- Deploy workstation operating system updates and security patches in coordination with IT.
- Provide a visible, collaborative on‑site presence and communicate via customer collaboration tools.
- Escort and host instrument vendors, and coordinate instrument readiness for relocation or decommissioning.
- Support established small‑molecule DMPK bioanalytical workflows when capacity permits.
Requirements
- Bachelor’s degree or equivalent formal academic/vocational qualification.
- Comparable to 6+ years of relevant experience (or an equivalency of education, training, and hands‑on experience).
- Hands‑on experience with oligonucleotide LC‑MS bioanalysis, including sample extraction, ion‑pairing chromatography, and quantitation on SCIEX and Shimadzu platforms.
- Demonstrable depth in LC‑MS instrument hardware maintenance and user‑level repair, plus management of instrument software and controlling computers.
- Familiarity with bioanalytical workflows—sample preparation, bioanalysis, and data review—and ability to ramp across multiple assay types.
Qualifications & Skills
- Strong instrument and computer‑systems background enabling user‑level repairs, software updates, and license administration.
- Ability to manage software version control, operating‑system updates, and hardware lifecycle for LC‑MS platforms.
- Effective communication with diverse groups; ability to convey information clearly.
- Physical ability to work upright, stationary, or standing for typical working hours and lift/move objects up to 25 lb.
- Capability to work in non‑traditional laboratory environments and handle potential hazardous elements (e.g., infectious agents).
- Proven ability to prioritize and handle multiple projects under pressure.
Work Environment
Thermo Fisher Scientific values employee health and wellbeing, encouraging a balanced environment where staff can thrive. This role may involve exposure to potentially hazardous elements typical of healthcare or laboratory settings. The employee must be able to communicate effectively, work upright or stationary, lift up to 25 lb, and use standard office equipment and technology proficiently.