Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
This is a fully onsite role based at our customer’s site in Upper Providence, 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.
Role Summary:
Perform biological assays and GMP sample testing to support drug development and commercial projects, with a primary focus on routine GMP sample testing support, cell banking activities, and execution of all associated project and sample-testing tasks. The role reliably conducts complex sample preparation and analysis following validated and experimental procedures with limited supervision, maintains data integrity in accordance with SOPs, protocols, and product specifications, and works collaboratively with project teams to support method execution, troubleshooting, and continuous improvement of bioassay workflows. Key responsibilities include:
Key responsibilities:
- Performing routine GMP sample testing for cell-based potency and other biological assays in support of development and commercial products, following approved methods and SOPs.
- Executing sample receipt and testing activities in compliance with GMP and internal quality systems.
- Maintaining and expanding mammalian cell lines, including routine cell culture, characterization, and generation of project-specific cell banks for bioassay use.
- Supporting qualification, validation, and transfer of bioassays into GMP laboratories and/or external testing sites.
- Applying aseptic techniques and standardized laboratory procedures to minimize contamination risk and ensure assay robustness and reproducibility.
- Documenting all experimental activities in electronic and/or paper laboratory notebooks; performing self-review of data and preparing data packages for QC review and reporting.
- Assisting in troubleshooting assay performance issues and implementing corrective and preventive actions, escalating issues appropriately.
- Collaborating with project scientists, to ensure on-time delivery of sample testing and clear communication of results and issues.
- Adhering to all safety, data integrity (ALCOA+), and compliance requirements within Client policies and procedures, and supporting continuous improvement of laboratory ways of working.
Education and Experience:
- PhD within Chemistry ( Organic/ Synthetic Chemistry) and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)
- OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)
- OR BS degree and Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)
- Demonstrated experience with mammalian cell culture, cell banking, and aseptic techniques.
- Prior experience performing GMP sample testing, preferably in cell-based potency bioassays or related biological assays.
- Experience designing, troubleshooting, and executing bioassay experiments with some supervision.
- Proven ability to analyze data, interpret results, and report findings in laboratory notebooks and standardized report formats.
- Experience performing and analyzing cell-based potency bioassays in a pharmaceutical/biotechnology or academic environment.
- Hands-on experience culturing immortalized adherent and suspension cell lines; familiarity with generation and characterization of research or GMP cell banks.
- Working knowledge of GMP principles, data integrity requirements, and laboratory quality systems.
- Experience using laboratory automation and electronic data systems (e.g., ELN, LIMS) is a plus.
- Prior experience in an academic institution, biotechnology or pharmaceutical industry, preferably in a regulated (GMP/GLP) setting.
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.
Knowledge, Skills and Abilities:
- Excellent communication skills, both written and verbal, with the ability to clearly convey experimental plans and results to cross-functional teams.
- Strong technical writing skills for protocols, reports, and assay documentation.
- Demonstrated high level of scientific rigor, integrity, and ownership of assigned testing activities.
- Ability to work independently with limited supervision while effectively collaborating within cross-functional project teams.
- Strong organizational skills and ability to prioritize and manage multiple sample queues or testing activities to meet timelines.
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!
