Senior Scientist - Assay Development & Quality Control - BioForge : Job Details

Senior Scientist - Assay Development & Quality Control

Location: Pittsburgh, PA | Full Time |

BioForge's mission is to accelerate innovations and breakthroughs in both the development and manufacturing of precision medicines to speed their delivery, use, and impact.

A fundamental shift is occurring in how medicines and therapeutics are delivered to people. Treatments are increasingly moving from an era of chemicals and drugs towards gene and cell therapies for multiple and diverse conditions such as cancer, blindness and degenerative neural diseases. Furthermore, precision biologic medicines – by their very nature – need manufacturing solutions capable of rapid, efficient and cost-effective switching between therapy productions without switching production tools or processes. How do we deliver a billion therapies, a hundred, ten thousand, or a hundred thousand at a time?

Such a shift requires fundamentally new approaches and innovations in the manufacturing of such gene and cell therapies. These approaches will bring to bear new and emerging technologies such as artificial intelligence/machine learning, continuous-flow fluidic processing, in-line sensing and control and closed-system automated design to develop next-generation manufacturing tools. With innovation comes the need for quality—demanding robust QC and QA tools that ensure standards are upheld throughout the R&D pipeline.

We are seeking a Senior Scientist with expertise in analytical method development, assay design, and quality control. This role is central to developing, optimizing, and executing assays that characterize critical quality attributes (CQAs) across a range of biologic platforms. The ideal candidate has a deep command of assay technologies and is equally comfortable executing validated protocols and developing novel methods from scratch.

You will work as a key member of our analytical and R&D team, leading the development and execution of both routine and innovative assay platforms to support the characterization of complex biologics. This role offers the opportunity to shape and implement critical quality control strategies, contribute to cross-functional platform development, and design custom analytical workflows that support scalable, high-quality biomanufacturing. It is ideal for a technically advanced scientist passionate about continued assay development, building quality systems, and enabling the future of biologics through analytical science.

• Design, develop, and optimize analytical assays to support quality control and product characterization
• Independently lead method development efforts across biochemical, molecular, and cell-based techniques
• Evaluate and measure product quality attributes and create CoAs
• Create standard operating procedures (SOPs) and qualification reports
• Perform assay qualification and validation in alignment with regulatory expectations (e.g., precision, accuracy, linearity, specificity)
• Collaborate with R&D, manufacturing, and regulatory teams to ensure analytical strategies meet program goals
• Investigate assay failures, troubleshoot technical issues, and drive continuous improvement
• Maintain rigorous documentation and ensure compliance with internal and external quality standards

• PhD or MS in Biology, Biochemistry, Bioengineering, Analytical Chemistry, or related field
• 5-8 years of laboratory experience in a QC, assay development, or analytical environment
• Proven hands-on expertise with multiple assay formats, such as:
• Spectroscopy (UV-Vis, fluorescence, absorbance)
• Electrophoresis (gel, capillary)
• PCR/ddPCR/qPCR
• ELISA or immunoassays
• Cell-based assays
• Chromatography or particle sizing
• Microscopy
• Demonstrated ability to develop and qualify custom assays
• Strong documentation and technical writing skills
• Experience working in regulated environments (GMP, GLP, ISO)

Desirable:

• Strong interpersonal skills and the ability to work as part of a team
• Familiarity with statistical tools for method validation (e.g., DOE, regression, precision studies)
• Experience transferring methods between teams or to external partners
• Strong project ownership and ability to work independently in a fast-paced setting
• Strong interpersonal skills and the ability to work as part of a team for company wide goals

• A collaborative, forward-thinking environment with cutting-edge projects
• Hands-on access to state-of-the-art analytical tools
• Competitive compensation and benefits

To apply, please submit the following materials to [email protected] with the subject line:

“QC”



Application Deadline: August 30, 2025

Start Date: October 1, 2025