Principal Process Development Biochemist – Technical Operations Lead

This position is onsite in Boston until the office relocates to Hopkinton, MA in August 2026.

Provide technical leadership and operational excellence across a diverse reagent manufacturing portfolio. Perform routine and complex syntheses, labeling, purification and analytical support for a wide variety of chemicals and biologics, that may include amino acids, proteins, nucleotides, nucleosides, ligands, custom compounds and other chemicals. May use a combination of synthetic, enzymatic or cell culture techniques and synthetic, analytical, functional assay, and laboratory skills.

Serves as the primary technical resource for manufacturing troubleshooting, process validation, new product introductions (NPI), and technology transfers from R&D. Independently provides solutions to complex technical problems across multiple reagent platforms. Receives general direction and utilizes specialized knowledge in determining objectives, processes and methods to ensure manufacturing excellence and continuous improvement.

• Lead troubleshooting of manufacturing issues across multiple reagent platforms using systematic root cause analysis methodologies.
• Independently resolve complex technical problems impacting production yield, quality, or throughput.
• Execute product manufacturing and analytical testing according to established procedures, record data, interpret results and validate data quality.
• Serve as laboratory technical expert across multiple reagent technologies.
• Serve as technical escalation point for production teams encountering process deviations or equipment issues.
• Design, execute, and document validation protocols (IQ/OQ/PQ) for new processes, equipment, and raw materials.
• Lead raw material qualification studies to ensure supply chain continuity and product quality.
• Participate in or lead deviation investigations and CAPA implementation.
• Lead or support technology transfers from R&D to manufacturing, ensuring seamless scale-up and process robustness.
• Coordinate cross-functional NPI activities with R&D, Quality, Supply Chain, and Production teams.
• Develop and optimize manufacturing processes for new reagent products across multiple technology platforms.
• Assess manufacturing readiness and identify equipment, facility, or capability gaps for new products.
• Lead Continuous Improvement (CI) projects to optimize manufacturing or test methods, reduce costs, and improve efficiency.
• Independently develop new compounds, analytical methods, or process improvements to support custom or catalog products.
• Create, update, and review manufacturing SOPs, batch records, and technical documentation.
• Fully responsible for significant technical deliverables and may lead manufacturing project teams.

• May represent the manager or department at internal or external functions.
• May interact with customers on technical issues using specialized knowledge providing problem resolution.
• May include labeling (including radiolabeling), dispensing, packaging of reagents and final product.
• May include performing ligand binding assays, bead conjugation, microfluidic device assembly, or radiochemistry using appropriate instrumentation.
• Work safely and in compliance with all applicable company, federal and local regulations including GMP guidelines, handling of hazardous biological chemicals and radiation safety protocols.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

• Bachelor’s degree in life or natural sciences and 8 years of lab experience

OR

• Master’s degree in life or natural sciences and 6 years of lab experience

OR

• PhD degree in life or natural sciences

• Strong familiarity with modern analytical tools including HPLC, mass spectrometry, flow cytometry, NMR, UV-Vis, or similarly related equipment, with deep understanding of analytical chemistry, organic chemistry, or biochemistry.
• Proven track record in manufacturing troubleshooting, root cause analysis, and implementing effective solutions to complex technical problems impacting production.
• Strong…