Senior Specialist MS&T (Analytical Sciences)
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The Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site, focusing on Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing and Quality Control. Acting as Analytical Method and PAT SME, the role leads the use of the latest innovations in technology and automation to create a productive, forward-looking workplace.
Responsibilities
* Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching associate staff. Provide technical leadership for:
o Experimental design, execution, data analysis and interpretation.
o Development, transfer and qualification of assays.
o Lead and support various MS&T organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
o Technical point of contact for Process Analytical Technologies (PAT).
o Authoring and reviewing documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions.
o Technical lead for characterization testing, ensuring testing conducted either internally or externally.
o Serving as a key member during internal audits and external inspections/audits.
o Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
Qualification And Experience
* Bachelor’s degree (or higher) in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
* Excellent oral and written communication skills with the ability to articulate understanding of process science.
* Experience with analytical testing supporting 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 characterization studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections, and/or working with external contract organizations 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 keep the patient at the heart of all we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces diversity and values bringing talented and committed people together.
Please contact the Talent Acquisition Advisor assigned to this role if you need any support during our recruitment process.
We are committed to flexible working where possible and have introduced a new hybrid working model for office-based colleagues. Please speak to us about what flexibility means to you during your application.
Required Skills
Adaptability, Assay Development, Biochemical Assays, Cell-Based Assays, Cell Cultures, Chemistry, Data Analysis, Detail-Oriented, Documentation, Estimation and Planning, High-Performance Liquid Chromatography (HPLC), Interdisciplinary Collaboration, Interpersonal Relationships, Liquid Chromatography-Mass Spectrometry (LC-MS), Mammalian Cell Culture, Mass Spectrometry (MS), Process Design, Process Improvements, Project Planning, Regulatory Compliance, Root Cause Analysis (RCA), Statistical Process Control (SPC), Technical Leadership
Preferred Skills
Current Employees apply HERE. Current Contingent Workers apply HERE.
Additional Information
Job Posting End Date: 10/17/2025. Travel and relocation considerations, visa sponsorship, and flexible work arrangements are noted as applicable.
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