▷ [Apply Now] Senior Specialist MS&T (Analytical Sciences)

Job Description

The Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site. In particular Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing and Quality Control, Acting as Analytical Method and PAT SME while taking a lead in utilising the latest innovations in technology and automation to create a workplace of the future.

Responsibilities:

- Serving 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 of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), 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

Qualification and Experience

- Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry,
- Have 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 organisation 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 very heart of all that 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 the value of bringing diverse, talented, and committed people together.

Required Skills:

- Adaptability
- Assay Development
- Biochemical Assays
- Cell-Based Assays
- Cell Cultures
- Chemistry
- Data Analysis
- Data Interpretations
- Detail-Oriented
- Documentations
- 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:

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