Work Schedule Standard (Mon-Fri) Environmental Conditions Office
Job Description
Position: Scientist
ONSITE:
This is a fully onsite role based at our customer’s site in King of Prussia, PA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. 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. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.
Key responsibilities:
- The candidate will support the development, characterization, scale-up, and technology transfer of downstream unit operations for biopharmaceutical drug-substance manufacture. The role will execute defined experimental and technical work across chromatography and filtration operations, generate reliable and traceable data, interpret results, resolve technical issues, and contribute to project decisions and documentation.
- Key responsibilities
- 1. Experimental and technical delivery
- Plan and execute downstream process-development studies across unit operations such as capture, intermediate and polishing chromatography, depth filtration, viral filtration, and ultrafiltration/diafiltration.
- Execute agreed experimental plans safely and efficiently, ensuring that studies are appropriately prepared, controlled, documented, and completed to the expected quality.
- Perform routine or defined experiments using established protocols, with appropriate guidance during unfamiliar or higher-complexity work.
- Independently plan and manage experiments of increasing complexity, adapting study execution within an agreed technical strategy and coordinating the activities needed to complete a defined work package.
- Operate and maintain relevant laboratory equipment after qualification and training, and identify equipment, material, or execution issues that could affect study quality or delivery.
- 2. Data analysis, interpretation, and technical recommendations
- Analyze experimental and process data using appropriate statistical, digital, and visualization tools.
- Assess data quality, identify trends and atypical results, and distinguish observations from conclusions.
- Perform prescribed analyses, contribute to basic interpretation, and escalate unexpected or complex findings. Independently interpret data, draw conclusions, identify trends, compare alternatives, and propose technically supported next steps.
- Translate results into concise recommendations for the responsible project scientist or workstream lead, including limitations, unresolved questions, and any need for additional work.
- Apply a prediction-led or model-informed approach where appropriate, while retaining experimental verification and accountable scientific review.
- 3. Problem solving and troubleshooting
- Identify and troubleshoot technical and experimental issues affecting chromatography, filtration, recovery, impurity clearance, process robustness, or equipment performance.
- Address routine issues using established methods and seek support when the potential consequence exceeds the contractor’s assigned authority or experience.
- Resolve complex issues independently or with minimal guidance, propose solutions supported by experimental evidence, and contribute to process improvement.
- Escalate material risks promptly, including potential impacts to safety, data integrity, project timelines, process understanding, or transfer readiness.
- 4. Process understanding and development support
- Contribute to studies supporting process optimization, robustness, scale-up, small-scale model qualification, process characterization, and technology transfer, as applicable to the assigned work.
- Evaluate process performance against agreed objectives for yield, product quality, impurity clearance, operability, and robustness.
- Help maintain line of sight between experimental objectives, resulting data, technical conclusions, and the downstream process-development decision being supported.
- Identify opportunities to improve experimental efficiency, process understanding, or laboratory workflows without independently changing approved project strategy or controlled requirements.
- 5. Documentation and technical communication
- Maintain complete, accurate, contemporaneous, and traceable experimental records in the applicable approved systems.
- Prepare study summaries, data packages, technical presentations, and clearly bounded conclusions.
- Contribute sections to development reports, process-transfer documents, process-history summaries, and regulatory-supporting documentation under the review and approval of the accountable GSK author or technical lead.
- Communicate progress, findings, risks, and proposed next steps to scientific and cross-functional stakeholders in a concise and timely manner.
- Present assigned work in project, departmental, or technical forums when appropriate to the experience level and scope of the assignment.
- 6. Cross-functional and matrix working
- Collaborate with upstream development, analytical, formulation, MSAT, manufacturing, Quality, Regulatory, and CMC partners as required by the assigned downstream work.
- Coordinate study inputs, samples, analytical testing, dependencies, and technical handoffs within the defined work-package boundary.
- Share results early enough to support integrated project decisions and identify implications for connected unit operations or downstream deliverables.
- Participate actively in departmental and cross-functional teams.
- Independently represent downstream process development for a defined technical topic or work package when assigned, while referring project-level decisions to the accountable GSK lead.
- 7. Technology transfer and manufacturing interface
- Support preparation of process descriptions, technical packages, study summaries, and supporting data required for transfer to internal or external manufacturing organizations.
- Participate in transfer discussions and help resolve questions related to the assigned downstream operation.
- Support review of scale-up, engineering, or manufacturing observations against development knowledge.
- Clearly escalate issues requiring project, Quality, Regulatory, or manufacturing authority.
- 8. Technical capability and continuous improvement
- Maintain current knowledge of relevant downstream process-development methods, equipment, analytical interfaces, and emerging technologies.
- Participate in evaluation or implementation of improved methods, tools, automation, or laboratory workflows within the agreed assignment.
- Propose practical improvements supported by data or observed workflow needs.
- Provide method-specific training or day-to-day technical guidance to colleagues where the contractor has demonstrated competence and has been asked to do so.
- The role does not include formal people-management, performance-management, or organizational capability accountability. 9. Safety, quality, compliance, and data integrity
- Perform all work in accordance with applicable safety, Quality, data-integrity, information-protection, and laboratory requirements.
- Complete required training before independently executing assigned activities.
- Identify and report potential safety, compliance, equipment, or data-integrity concerns.
- Support investigations and corrective actions relevant to the contractor’s work, without assuming approval or decision authority that has not been explicitly assigned.
- Ensure that technical conclusions do not extend beyond the evidence generated and reviewed.
- 10. Contractor delivery expectations
- Deliver the agreed experimental work packages, data analyses, technical summaries, documentation contributions, and transfer support within the six-month assignment.
- Maintain a transparent work plan covering deliverables, dependencies, risks, and required decisions.
- Communicate emerging constraints or potential milestone impacts early.
- Work independently within the agreed statement of work while maintaining appropriate technical alignment with the designated GSK lead.
- Recognize that access to systems, records, or meetings does not confer approval, delegation, or accountable decision authority.
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) OR PhD
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.
Working Environment:
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.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!