FSP Scientist

Thermo Fisher Scientific•King of Prussia, PA

20h•Onsite

About The Position

The Scientist will provide downstream process-development support for biopharmaceutical drug-substance manufacture at a customer site in King of Prussia, Pennsylvania. The role supports development, characterization, scale-up, and technology transfer of downstream unit operations, including chromatography and filtration. The Scientist executes experimental work, generates and analyzes reliable, traceable data, troubleshoots technical issues, and contributes to project decisions and documentation within an agreed assignment and under the appropriate technical oversight. The position involves planning and conducting studies across capture, intermediate and polishing chromatography, depth filtration, viral filtration, and ultrafiltration/diafiltration. Work may support process optimization, robustness, scale-up, small-scale model qualification, process characterization, and technology transfer. The Scientist assesses process performance against objectives such as yield, product quality, impurity clearance, operability, and robustness, and communicates conclusions, limitations, risks, and proposed next steps. The Scientist maintains accurate experimental records and contributes study summaries, data packages, presentations, development reports, process-transfer documents, process-history summaries, and regulatory-supporting documentation. The role collaborates with upstream development, analytical, formulation, MSAT, manufacturing, Quality, Regulatory, and CMC partners, and supports transfer discussions and manufacturing interfaces. All work must follow applicable safety, Quality, data-integrity, information-protection, and laboratory requirements. The assignment is expected to be delivered within six months; it does not include formal people-management or organizational capability accountability. This is a fully onsite position at the customer’s site in King of Prussia, PA. Applicants 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 and comparable relevant experience of 2 or more years; alternatively, a PhD.
An equivalent combination of appropriate education, training, and/or directly related experience may be considered.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, including a 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 with proficiency.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Ability to work in non-traditional work environments and potentially hazardous healthcare or laboratory environments.

Responsibilities

Plan and execute downstream process-development experiments across chromatography, filtration, and ultrafiltration/diafiltration operations.
Operate and maintain laboratory equipment after qualification and training; identify issues that could affect study quality or delivery.
Analyze experimental and process data using appropriate statistical, digital, and visualization tools; assess data quality and identify trends or atypical results.
Interpret results, draw evidence-supported conclusions, compare alternatives, and recommend next steps, escalating complex findings as appropriate.
Troubleshoot technical and experimental issues involving chromatography, filtration, recovery, impurity clearance, process robustness, and equipment performance.
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 bounded conclusions; contribute 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.
Coordinate study inputs, samples, analytical testing, dependencies, and technical handoffs with cross-functional partners.
Support preparation of technical packages and transfer discussions for internal or external manufacturing organizations; help address questions related to assigned downstream operations.
Maintain current knowledge of downstream process-development methods, equipment, analytical interfaces, and emerging technologies; participate in evaluation or implementation of improvements within the assignment.
Provide method-specific training or day-to-day technical guidance when competent and asked to do so.
Follow applicable safety, Quality, data-integrity, information-protection, and laboratory requirements; complete required training and report concerns.
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 risks early.