MSAT Senior Scientist: Analytical Services

MSAT Senior Scientist – Analytical Services

The MSAT Senior Scientist - Analytical Services will provide technical and scientific expertise to support the introduction of new products to site as well as commercial manufacture of therapeutic proteins within a GMP biopharmaceutical manufacturing environment. This role requires technical leadership across multiple late-stage programs and will involve activities including, but not limited to, analytical technology transfer/introduction, method qualification, analytical investigations, and execution of analytical laboratory studies.

 

A key requirement for the successful candidate will be the ability to lead the introduction and implementation of analytical test methods to the in the MSAT laboratory for new products and processes. The successful candidate will leverage their analytical expertise and product knowledge to support ongoing process optimization, analytical method improvement, specification setting, and regulatory compliance activities. The ideal candidate will serve as a key analytical subject matter expert (SME) for troubleshooting analytical issues, supporting investigations, assessing the impact of manufacturing process changes on analytical performance, and ensuring that analytical methods remain fit for intended use throughout the product lifecycle.

 

The role will also include designing, coordinating, and executing analytical studies to support small scale process confirmation and verification, process characterization, comparability assessments, method performance evaluations, and late-stage process and product development initiatives. The candidate will collaborate extensively with Manufacturing, QC, MSAT Technical Services and Technical transfer teams, Quality Assurance, Regulatory Affairs, and external partners to ensure robust analytical support for commercial and clinical manufacturing operations..

 

Department Description

As MSAT Senior Scientist you will join an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the MSAT Analytical Services Lead.  

 

Your Responsibilities - Essential Duties and Responsibilities:

• • • • Provide analytical support for GMP commercial and clinical manufacturing operations, ensuring timely resolution of analytical issues and maintenance of analytical control strategies.
      • Act as an analytical SME to support QC with technology transfer, analytical method validation and verification.
      • Support QC with troubleshooting method performance and scientific investigations (deviations and laboratory investigations).
      • Lead and execute analytical technology transfer activities into the MSAT lab for new products, ensuring methods are scientifically appropriate for the stage of product and process development.
      • Collaborate with external testing laboratories to coordinate outsources analytical testing.
      • Provide expertise in protein characterization and analytical testing, including chromatographic, electrophoretic, spectroscopic, potency, impurity, and immunological assays.
      • Design and oversee analytical aspects of laboratory small scale studies with a high level of scientific autonomy. Evaluate analytical results in the context of critical quality attributes, process-related impurities, product-related impurities and overall process performance.
      • Support regulatory inspections and health authority audits through preparation of technical documentation and presentation of analytical data.
      • Support establishment, qualification, and continuous improvement of analytical laboratory capabilities and equipment.
      • Mentor and coach scientists and laboratory personnel, developing analytical expertise across the organization.
      • Ensure all activities are performed in accordance with company and regulatory expectations.
      • Demonstrate flexibility in assuming additional responsibilities as required by the business.
      • Act as a role model for the MSAT function and broader organization through adherence to company values and quality culture principles.

 

 

Your Profile: The ideal candidate for this position will have the following:

 

Education:

• PhD in Analytical Chemistry, Biotechnology, Biochemistry, Pharmaceutical Sciences, or related scientific discipline preferred.
• Master's or Bachelor's degree in a relevant scientific discipline with significant relevant industry experience will also be considered.

 

Knowledge/Experience/Technical Competencies:

• Minimum of 6 years' experience in analytical development, QC, MSAT Analytical, or related functions within a biopharmaceutical manufacturing environment, although the position level will be commensurate with experience.
• Strong knowledge of analytical method lifecycle management and current Good Manufacturing Practices (cGMP).
• Proven experience leading analytical technology transfer activities within clinical and/or commercial manufacturing environments.
• Experience authoring and reviewing analytical method validation, verification, transfer, and comparability protocols and reports.
• Demonstrated expertise in protein characterization techniques, including:
  • HPLC/UPLC methods (SEC, IEX, RP, HIC)
  • CE-SDS and cIEF
  • ELISA and ligand-binding assays
  • UV-Vis spectroscopy
  • Potency and enzyme activity assays
  • Aggregation and impurity analysis
  • Biophysical characterization methods
• Experience with troubleshooting of analytical methods and laboratory investigations.
• Working knowledge of statistical tools used for analytical method performance evaluation and data trending.
• Experience supporting regulatory inspections and responding to technical queries from regulatory agencies.

 

 

 

Personal skills:

• Strong scientific and technical problem-solving capabilities.
• Excellent attention to detail and commitment to data integrity.
• Ability to work independently while effectively contributing to cross-functional teams.
• Strong project management and organizational skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills.
• Effective presentation and technical report-writing abilities.
• Ability to influence and collaborate across multiple functional areas.
• Strong mentoring and coaching capabilities.
• Demonstrated ability to communicate complex analytical concepts to both technical and non-technical stakeholders.
• Excellent cross-functional collaboration and relationship-building skills.

 

 

If you have the ability to thrive in a dynamic and fast-paced environment, don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.  Apply now! Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie   

WuXi Biologics is an equal opportunities employer.