Senior Scientist, Process Development Analytics

Job Overview

The Senior Scientist, Process Development Analytics, is a proactive, strategic, and hands‑on technical lead who will drive and execute on team objectives in a client‑facing role. They will support the development of protein biologics through analytical characterization of process development intermediates and establishment of analytical methods.

• Design, lead, and execute method development in support of internal and external partners for use within quality control departments for clinical and commercial manufacturing.
• Lead, execute, review, and present high‑throughput testing of in‑process samples for process development work packages.
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives.
• Coordinate with management for the day‑to‑day execution of experiments in the lab to ensure proper personnel coverage for timely completion.
• Author high‑quality documents, including technical reports, SOPs, and experimental protocols.
• Identify, evaluate, and implement new and existing technologies to improve testing efficiency, control and understanding.
• Provide alignment between development and quality control laboratories for upcoming sample transfer and testing requests.
• Coordinate technical transfer of established methods to quality control and clients.
• Provide technical support to quality control and manufacturing floor activities; serve as PD representative and participate in cross‑functional meetings.
• Oversee ordering and tracking of routine and client‑billable consumables.
• Lead, train, and mentor junior lab staff.
• Interpret analytical data and understand relation to manufacturing process steps; review data packages and compile slides to present at client project presentations.
• Contribute to the overall operations of process science lab and infrastructure improvements.

• University degree with 8+ years of related experience, Master’s degree with 5+ years, or PhD with 2+ years.
• Hands‑on experience with analytical techniques such as HPLC/UPLC, cGE/iCIEF, bioassay, activity assay, ELISA, qPCR, and microbial testing.
• Experience with monoclonal antibodies, bispecifics, fusion proteins, and enzymes is preferred.
• Experience with method development, qualification, and validation.
• Knowledge of protein manufacturing processes (upstream/downstream) is preferred.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, SharePoint).
• Ability to work independently and as part of local or global teams.
• Excellent customer service skills and ability to meet client project deadlines.
• Flexibility to switch between projects.
• Self‑motivated, accountable, inquisitive, with strong organization and communication skills.

• Laboratory environment working with chemical reagents and analytical equipment.
• Use of personal protective equipment as required.
• Normal office working conditions: computer, phone, files, fax, copier.
• Fast pace and high demands for job completion.
• Physical requirements:
  
  frequent lifting up to 10 lbs, frequent standing/walking, frequent sitting.

Base Pay Range: $120,000 - $150,000. The base pay range listed for this position is the anticipated annual base salary range for this role. Actual compensation will be determined based on factors such as seniority, education, training, relevant experience, geography, and job responsibilities.