Senior Specialist MS&T (DS Process Science)
The Senior Specialist MS&T (DS Process Science) delivers a range of technical support to the Drug Substance Business, supporting technical investigations within the Integrated Process Team, and leading significant projects in the MS&T laboratory while fostering a culture of safety, quality, and continuous improvement.
Responsibilities
Lead, design, support, and execute experimental designs, data analysis, and interpretation to resolve complex deviations.
Lead process improvement and troubleshooting with an end-to-end product focus.
Assist in and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.
Execute experimental design, data analysis, and interpretation.
Support the process sciences team during small scale model run execution, including buffer preparation, equipment set-up, run execution, sampling, and data analysis.
Author and review standard operating procedures (SOPs), protocols, and reports as required.
Support continuous improvement through Lean Six Sigma methodologies.
Support alignment and knowledge exchange with development organizations, other commercial nodes, and external manufacturing partners.
Qualifications
Demonstrated leadership and change-management skills with a continuous-improvement focus.
Proven track record of delivering high performance through development and coaching of a team.
Evidence of continuous professional development.
Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
Desire to continuously learn, improve, and develop.
Technical Experience
Demonstrated leadership and a proven track record of delivering projects of technical complexity.
Knowledge of and experience in applying Six Sigma and Lean methodologies.
Desirable evidence of continuous professional development.
Experience in drug substance process development, process characterization studies, downstream technology, and/or process modeling.
Experience in designing and executing experimental programs in the laboratory, with a working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Expert software).
Technical experience in manufacturing biological molecules at the lab, pilot, and/or commercial scale.
Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
Technical writing skills.
A master's degree in Biological Sciences, Chemistry, Chemical Engineering, or Biological Engineering with 2+ years of experience, or a bachelor's degree in the same fields with 4+ years of experience.
Experience leading technical-related projects.
Required Skills
Data Analysis, Estimation and Planning
Immunochemistry, Immunology
Manufacturing Quality Control, Microbiology
Process Design, Process Improvements, Project Planning
Regulatory Compliance, Root Cause Analysis (RCA)
Six Sigma, Standard Operating Procedure (SOP)
Technical Support, Technical Writing, Technology Transfer
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