DS Process Science

Orion Group Life Sciences are currently recruiting a Senior Specialist MS&T (DS Process Science) on behalf of our Multinational Biopharmaceutical Client based in Swords on a 11-Month contract - maternity leave cover.

The Senior Specialist MS&T (Downstream Process Sciences) delivers a range of technical support to the Drug Substance Business: supporting technical investigations within the Integrated Process Team, supporting significant projects in the MS&T laboratory, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.
 
Primary Responsibilities:

• Leading, designing, supporting and executing downstream technical projects (e.g. UFDF (Ultrafiltration/Diafiltration), Chromatography, filtration) at small scale to support large-scale manufacturing.
• Executing experimental design, data analysis and interpretation to resolve technical projects and complex investigations/deviations.
• Supporting, training and mentoring the Process Sciences team during small scale model run execution, including buffer preparation, lab-scale equipment set up, run execution, sampling and data analysis.
• Author and review standard operating procedures (SOPs), protocols and reports as required.
• Identifying and supporting continuous improvement opportunities through Lean Six Sigma methodologies.
• Leading process improvement, technical problem-solving and troubleshooting with end-to-end product focus. Assist in investigations, ensuring effective Root Cause Analysis and CAPAs.
• Supporting alignment and knowledge exchange with departments, development organizations, other commercial nodes and external manufacturing partners.

 
Qualification and Experience General Competencies:

• 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 in downstream drug substance manufacturing, process development, process characterisation studies, downstream technology, and/or process modeling.
• Technical experience in the drug substance manufacture of biological molecules at the lab, pilot and/or commercial-scale.
• Experience in designing and executing experimental programs in the laboratory, including small scale lab experience, e.g. AKTA Avant chromatography, UFDF, NFF (Normal Flow Filtration). Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Demonstrated leadership and proven track record of delivering projects of technical complexity
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical writing skills.
• Knowledge of and experience in applying structure problem solving, Six Sigma and Lean methodologies.
• Desirable evidence of continuous professional development.

 Minimum Education/Experience:

• A Masters degree in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering with 2+ years experience or a Bachelor’s degree in Biological Sciences/ Chemistry /Chemical Engineering/Biological Engineering with 4+ years experience
• Experience leading technical related projects.

 Required Skills:

Data Analysis, Estimation and Planning, Chromatography, DOE, 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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