Overview
The Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support at the site. In particular, Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing and Quality Control, acting as Analytical Method and PAT SME while leading the use of the latest innovations in technology and automation to create a workplace of the future.
Responsibilities
* Serve as a biologics analytics and characterization subject matter expert, providing technical input to teams and coaching to associate staff; provide technical leadership for experimental design, execution, data analysis and interpretation.
* Development, transfer and qualification of assays.
* Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
* Technical point of contact for Process Analytical Technologies (PAT).
* Authoring and reviewing documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions.
* Technical lead for characterization testing, ensuring testing conducted either internally or externally.
* Serving as a key member during internal audits and external inspections/audits.
* Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
Qualifications
* Bachelor’s degree (or higher) in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
* Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science.
* Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules.
* Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
* Analytical chromatography experience ideally with some Mass Spectrometry experience.
* Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisations for development and/or manufacturing.
* Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
* Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
We are an equal opportunity employer and value diversity.
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