Work Schedule

Environmental Conditions

Job Description

Fully onsite in Collegeville, PA:
At Thermo Fisher Scientific, you’ll 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.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:
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.

Overview:

This Statement of Work describes a dedicated on-site service offering that provides hands-on oligonucleotide LC–MS bioanalytical capacity to the customer’s DMPK (Drug Metabolism and Pharmacokinetics) group, backed by analytical instrument field support. The service is designed to deliver the recurring oligonucleotide bioanalysis workload while keeping critical LC–MS platforms operational and analytically ready.

Individuals need strong instrument and computer-systems background, enabling user-level repairs, software and operating-system updates, and license administration to be handled in-house and bridging coverage until vendor service engineers can attend site. Individual will flex across bioanalysis and instrument support according to weekly demand, providing a consistent, approachable point of contact for the customer’s scientists and laboratory teams.

Objectives:

• Deliver responsive, on-site oligonucleotide LC–MS bioanalytical support, scaled to the weekly study schedule.

• Maximize uptime and analytical readiness of in-scope LC–MS 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 customer’s scientific and laboratory support teams.

Scope of Service:

The primary focus of the service is hands-on oligonucleotide bioanalytical support to the DMPK group, scaled to the volume of work required each week. This capacity is intended to help deliver the recurring portfolio of in-vitro and in-vivo oligonucleotide studies on schedule.

• Assay execution: Development and execution of oligonucleotide LC–MS bioanalytical workflows, including sample preparation, extraction, LC–MS 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 week’s study demand.

• Data integrity: Review and handling of analytical data in line with the customer’s quality and compliance expectations.

Instrument Upkeep & Real-Time Support:

The service also maintains in-scope analytical equipment in an operational state and provides immediate, user-level response to minor issues, minimizing downtime and bridging coverage until vendor service can attend site.

• Routine maintenance: Preventive maintenance, QC checks, and consumable management for in-scope LC–MS 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, License & Computer System Management:

The service maintains instrument software and the computer systems that control in-scope instruments, keeping acquisition workstations current, licensed, and aligned with the customer’s IT requirements.

• 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 customer’s IT function to avoid disruption to acquisition.

• License administration: Tracking and administration of instrument software licenses to maintain continuity of operation.

Coordination & On-Site Presence:

• Visible support: A consistent, approachable presence within the laboratory areas, supplemented by responsive communication via the customer’s collaboration tools.

• Vendor escort & coordination: Escorting and hosting instrument vendors on-site, and coordinating with the customer’s analytical and laboratory support functions.

• Instrument readiness: Preparing instruments for relocation, decommissioning, or related activities.

Small-Molecule Bioanalytical Support:

• 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.

Equipment in Scope:

The service covers analytical instrumentation across major and specialty LC–MS vendor platforms, with emphasis on the systems used for oligonucleotide bioanalysis, such as LC-MS platforms, Chromatography, Mass Spec, and supporting equipment.

Personnel & Hands-on experience with oligonucleotide LC–MS bioanalysis, including sample extraction, ion-pairing chromatography, and quantitation on SCIEX and Shimadzu platforms.

• 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 LC–MS 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.

Education:

• Bachelor's 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.

Work Environment:
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.