Scientist​/Senior Engineer – Drug Product Process Engineering

Job Overview

Scientist/ Senior Engineer – Drug Product Process Engineering.
You will serve as Process Engineering Lead, providing technical and project leadership for drug product formulation, fill/finish, inspection, and presentation‑specific activities. The role integrates process, product, manufacturing, quality, regulatory, and analytical information to ensure successful commercialization, robust lifecycle management, and reliable supply of assigned drug product SKUs.

• Serve as the SKU Lead for assigned commercial or late‑stage pipeline products, owning formulation, fill/finish, presentation, and lifecycle management.
• Lead or support commercial technology transfers, including facility‑fit assessments, make‑a‑batch assessments, process gap analyses, risk assessments, process characterization studies, and on‑site manufacturing support.
• Act as Process Engineering Lead for parenteral unit operations (formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection).
• Plan, design, execute, and document laboratory, offline, and on‑site studies for process development, characterization, scale‑up, robustness, and lifecycle management.
• Provide technical leadership by integrating process understanding, product quality attributes, manufacturing performance, analytical data, regulatory commitments, and site capabilities.
• Support clinical and commercial manufacturing operations through capability analysis, troubleshooting, root‑cause analysis, non‑conformance investigations, corrective and preventive actions, and product impact assessments.
• Author and review technical protocols, study reports, process transfer documents, regulatory submission sections, and lifecycle management documentation.
• Partner with manufacturing sites and cross‑functional teams to assess and implement process changes, equipment changes, raw material changes, scale changes, site transfers, and process improvements while ensuring quality and supply continuity.
• Apply scientific and engineering principles (biochemistry, biophysics, statistics, chemical engineering, mechanical engineering) and data‑driven approaches to solve complex technical challenges.
• Lead or participate in global cross‑functional teams, influencing decision‑making and communicating risks across stakeholders.
• Deliver clear technical updates, progress reports, risk assessments, and recommendations to management, program teams, governance forums, and manufacturing partners.

• Doctorate or Master’s degree with 2 years of relevant experience, or Bachelor’s degree with 4 years of relevant experience.
• Preferred: M.S. or Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Pharmaceutics, Chemistry, Biochemistry, Biotechnology, or related discipline.
• 3+ years of experience in drug product process development, process engineering, commercialization, manufacturing sciences, or lifecycle management within the pharmaceutical or biotechnology industry.
• Experience supporting parenteral drug product development and manufacturing, including liquid and/or lyophilized presentations.
• Hands‑on experience with fill/finish unit operations (formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection, scale‑up).
• Experience leading or acting as SKU lead, process lead, or commercialization lead for late‑stage or commercial drug product programs.
• Experience with process characterization, scale‑down model development, scale‑up, technology transfer, process validation support, and commercial manufacturing support.
• Familiarity with aseptic processing, cGMPs, ICH guidelines, regulatory filings, pre‑approval inspections, and GMP documentation.
• Experience with non‑conformance investigations, root‑cause analysis, product impact assessments, process capability analysis, statistical process control, design of experiments, and risk assessment tools.
• Strong understanding of how process parameters, equipment, raw materials, scale, and site differences affect product quality.
• Ability to analyze large data sets using statistical tools, process monitoring approaches, modeling, or digital systems.
• Familiarity with…