Associate Research Scientist, Bioassay

Location: fully onsite at Upper Providence, PA. Applicants from any U.S. location are welcome. Relocation assistance is not provided; candidates are responsible for any relocation costs. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

Schedule

Standard (Mon‑Fri) work week.

Environmental Conditions

Laboratory setting with required personal protective equipment (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Role Summary

Perform biological assays and GMP sample testing to support drug development and commercial projects, focusing on routine GMP sample testing support, cell banking activities, and execution of associated tasks. Conduct complex sample preparation and analysis following validated and experimental procedures with limited supervision, maintain data integrity per SOPs, protocols, and product specifications, and collaborate with project teams to support method execution, troubleshooting, and continuous improvement of bioassay workflows.

Key Responsibilities

• Perform routine GMP sample testing for cell‑based potency and other biological assays in support of development and commercial products, following approved methods and SOPs.
• Execute sample receipt and testing activities in compliance with GMP and internal quality systems.
• Maintain and expand mammalian cell lines, including routine cell culture, characterization, and generation of project‑specific cell banks for bioassay use.
• Support qualification, validation, and transfer of bioassays into GMP laboratories and/or external testing sites.
• Apply aseptic techniques and standardized laboratory procedures to minimize contamination risk and ensure assay robustness and reproducibility.
• Document all experimental activities in electronic and/or paper laboratory notebooks; perform self‑review of data and prepare data packages for QC review and reporting.
• Assist in troubleshooting assay performance issues and implement corrective and preventive actions, escalating issues appropriately.
• Collaborate with project scientists to ensure on‑time delivery of sample testing and clear communication of results and issues.
• Adhere to all safety, data integrity (ALCOA+), and compliance requirements within client policies and procedures, and support continuous improvement of laboratory ways of working.

Education and Experience

• PhD in Chemistry (Organic/Synthetic) with ≥2 years relevant experience, or Master’s degree with ≥4 years experience, or BS degree with ≥6 years experience.
• 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.
• 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.
• Equivalency of education, training, and/or directly related experience may be considered.

Knowledge, Skills, and Abilities

• Excellent written and verbal communication skills; ability to convey experimental plans and results to cross‑functional teams.
• Strong technical writing skills for protocols, reports, and assay documentation.
• High level of scientific rigor, integrity, and ownership of assigned testing activities.
• Ability to work independently with limited supervision while collaborating effectively within cross‑functional project teams.
• Strong organizational skills; ability to prioritize and manage multiple sample queues or testing activities to meet timelines.

Working Environment

• Communicate and understand information with diverse groups of people.
• Work upright, stationary, and/or standing for typical working hours.
• Lift and move objects up to 25 pounds.
• May work in non‑traditional environments and be exposed to potentially hazardous elements, including infectious agents.
• Use standard office equipment and technology with proficiency.
• Perform successfully under pressure while prioritizing multiple projects or activities.

Benefits

• Competitive remuneration and annual incentive plan bonus.
• Healthcare coverage and a range of employee benefits.
• Opportunities for career development within an innovative, forward‑thinking organization.
• Company culture emphasizing integrity, intensity, involvement, and innovation.