MSAT Senior Scientist - UPS Technical Services

MSAT Senior Scientist – Upstream Technical Services

The MSAT Senior Scientist 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, Upstream Technology, Technical Studies in the MSAT Laboratory, Technology Transfer, Process Validation (PPQ, CPV), and Technical Support.  A key requirement for the successful candidate will be the ability to lead execution of laboratory-scale studies within the MSAT laboratory, to support process understanding, troubleshooting, process characterization, technology transfer, and continuous improvement initiatives.  The ideal candidate will possess extensive hands-on experience operating and troubleshooting cell culture experiments, performing routine testing, and translating laboratory findings into manufacturing process improvements. The role requires a strong experimental mindset, the ability to independently design and execute studies, and expertise in interpreting laboratory data to support decision-making for commercial manufacturing operations.  The position will serve as a key interface between Manufacturing, Process Development, Quality and Regulatory functions while driving scientific excellence within the MSAT laboratory.

Department Description

As MSAT Senior Scientist you’ll be joining 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 Technical Services Lead.  

Your Responsibilities - Essential Duties and Responsibilities:

• Design, execute and interpret upstream laboratory studies to support process characterization, process optimization, manufacturing investigations, technology transfers and lifecycle management activities.


• Independently operate and troubleshoot laboratory-scale fed-batch and perfusion bioreactor systems, including reactor preparation, inoculation, process monitoring, sampling and harvest operations.


• Perform cell culture activities including aseptic processing, seed train expansion, inoculum preparation, media/feed preparation and routine culture maintenance.


• Conduct daily analytical testing using benchtop instrumentation such as cell counters, metabolite analyzers, osmometers and protein concentration assays to monitor culture performance, productivity and process health.


• Investigate process deviations and unexpected experimental outcomes, utilizing data-driven root cause analysis to identify corrective and preventive actions.


• Author and review experimental protocols, study plans, technical reports, investigations and other GMP documentation associated with MSAT laboratory activities.


• Act as an SME for upstream cell culture processes, providing technical support for technology transfer, process validation, continued process verification (CPV), process monitoring and manufacturing investigations.


• Lead technical risk assessments and scientific evaluations in support of new product introductions and process lifecycle management.


• Analyze laboratory and manufacturing data, identify trends and recommend improvements to process performance, robustness and product quality.


• Collaborate with Manufacturing, Process Development, Quality, Engineering and Regulatory teams to resolve technical challenges and support successful process execution.


• Support regulatory inspections and customer audits through preparation and presentation of technical documentation and scientific justifications.


• Mentor scientists, engineers and manufacturing personnel in upstream processing, troubleshooting and data interpretation.


• Support the development, qualification and continuous improvement of MSAT laboratory capabilities, procedures and experimental platforms.


• Promote a culture of scientific excellence, compliance and continuous improvement while supporting departmental and site objectives.

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

Education:

• PhD in 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 6 years of experience supporting Upstream processes within a biopharmaceutical manufacturing, process development or MSAT environment.


• Strong practical experience operating and current Good Manufacturing Practices (cGMP).


• Proven experience leading upstream technology transfer activities within clinical and/or commercial manufacturing environments.


• Experience performing routine analytical testing using laboratory-scale process monitoring equipment including:


• Cell counters (Cedex, Vi-Cell or equivalent)


• Metabolite analyzers


• Osmometers


• pH and conductivity meters


• Protein concentration and product titer assays


• Proven ability to troubleshoot upstream process issues through laboratory experimentation and data-driven root cause analysis.


• Experience authoring and executing experimental protocols, Study plans, Technical reports, Process validation documentation and Investigation reports.


• Knowledge of statistical analysis tools and data trending techniques for process evaluation and CPV activities.


• Familiarity with Design of Experiments (DoE) methodologies and process characterization studies.


• Understanding of downstream process impacts on upstream process performance and product quality attributes.


• Experience supporting technology transfers into clinical or commercial manufacturing facilities.


• Strong understanding of cGMP requirements and application within laboratory and manufacturing environments.

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 technical concepts to both technical and non-technical stakeholders.


• Excellent cross-functional collaboration and relationship-building skills.


• Demonstrates alignment with the company’s core values and PROUD culture.

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.