FSP Scientist

Thermo Fisher Scientific•King of Prussia, PA

1d•Onsite

About The Position

The Scientist supports the development, characterization, scale-up, and technology transfer of downstream unit operations for biopharmaceutical drug-substance manufacture. The role plans and executes experimental work involving chromatography and filtration, generates and interprets reliable, traceable data, troubleshoots technical issues, and contributes to project decisions and documentation. Work is performed onsite at the customer’s site in King of Prussia, Pennsylvania, as part of Thermo Fisher Scientific’s Laboratories Functional Service Partnership team, which provides long-term support within customer organizations. The assignment is six months. The Scientist supports process optimization, robustness, scale-up, small-scale model qualification, process characterization, and technology transfer as applicable to assigned work. The position involves collaboration with cross-functional partners, preparation of technical materials and reports, and support for manufacturing transfer. The role has no formal people-management, performance-management, or organizational capability accountability, and project-level approval and decision authority remain with the accountable GSK lead or other designated authorities. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

Previous experience providing relevant knowledge, skills, and abilities comparable to 4 or more years; alternatively, a master’s degree plus comparable relevant experience of 2 or more years; or a PhD.
Ability to perform the duties of the role, including downstream process-development experimental, analytical, documentation, and technical communication work.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

An equivalency comprising an appropriate combination of education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

Plan and execute downstream process-development studies involving capture, intermediate and polishing chromatography, depth filtration, viral filtration, and ultrafiltration/diafiltration.
Prepare, control, document, and complete experiments safely and efficiently according to established protocols and agreed experimental plans.
Independently plan and manage experiments of increasing complexity within an agreed technical strategy, coordinating activities for defined work packages.
Operate and maintain qualified laboratory equipment, and identify equipment, material, or execution issues that may affect study quality or delivery.
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.
Interpret data, draw conclusions, compare alternatives, identify limitations and unresolved questions, and provide technically supported recommendations and next steps.
Troubleshoot technical and experimental issues affecting chromatography, filtration, recovery, impurity clearance, process robustness, or equipment performance; escalate material risks promptly.
Contribute to process optimization, robustness, scale-up, small-scale model qualification, process characterization, and technology-transfer studies as assigned.
Evaluate process performance against agreed objectives for yield, product quality, impurity clearance, operability, and robustness.
Maintain complete, accurate, contemporaneous, and traceable experimental records in approved systems.
Prepare study summaries, data packages, technical presentations, and contributions to development reports, process-transfer documents, process-history summaries, and regulatory-supporting documentation.
Communicate progress, findings, risks, and proposed next steps to scientific and cross-functional stakeholders; present assigned work when appropriate.
Collaborate with upstream development, analytical, formulation, MSAT, manufacturing, Quality, Regulatory, and CMC partners; coordinate study inputs, samples, testing, dependencies, and technical handoffs.
Support preparation of process descriptions, technical packages, study summaries, and data for transfer to manufacturing organizations; participate in transfer discussions and review scale-up, engineering, or manufacturing observations.
Maintain knowledge of downstream process-development methods, equipment, analytical interfaces, and emerging technologies; participate in agreed method, tool, automation, or workflow improvements.
Provide method-specific training or day-to-day technical guidance to colleagues when competent and asked to do so.
Perform work in accordance with safety, Quality, data-integrity, information-protection, and laboratory requirements; complete required training and report concerns.
Support investigations and corrective actions relevant to assigned work without assuming unassigned approval or decision authority.
Deliver agreed experimental work packages, analyses, summaries, documentation contributions, and transfer support within the six-month assignment; maintain a transparent work plan and communicate constraints or milestone impacts early.