About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Job Description
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:
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Leading, designing, supporting and executing downstream technical projects (e.g. UFDF(Ultrafiltration/Diafiltration), Chromatography, filtration) at small scale to support large-scale
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manufacturing.
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Executing experimental design, data analysis and interpretation to resolve technical projects and
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complex investigations/deviations.
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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.
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Author and review standard operating procedures (SOPs), protocols and reports as required.
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Identifying and supporting continuous improvement opportunities through Lean Six Sigma methodologies.
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Leading process improvement, technical problem-solving and troubleshooting with end-to-end product focus. Assist in investigations, ensuring effective Root Cause Analysis and CAPAs.
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Supporting alignment and knowledge exchange with departments, development organizations, other commercial nodes and external manufacturing partners.
Qualification and Experience:
General Competencies:
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Demonstrated leadership and change management skills with a continuous improvement focus
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Proven track record of delivering high performance through development and coaching of a team.
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Evidence of continuous professional development.
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Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
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Desire to continuously learn, improve and develop.
Technical:
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Experience in downstream drug substance manufacturing, process development, process characterisation studies, downstream technology, and/or process modeling.
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Technical experience in the drug substance manufacture of biological molecules at the lab, pilot and/or commercial-scale.
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Experience in designing and executing experimental programs in the laboratory, including smallscale lab experience, e.g. AKTA Avant chromatography, UFDF, NFF (Normal Flow Filtration).
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Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
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Demonstrated leadership and proven track record of delivering projects of technical complexity
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Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
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Technical writing skills.
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Knowledge of and experience in applying structure problem solving, Six Sigma and Lean methodologies.
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Desirable evidence of continuous professional development.
Minimum Education/Experience:
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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
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Experience leading technical related projects.
Required Skills:
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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
