MSAT Senior Scientist
The MSAT Senior Scientist will provide technical expertise to support the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. This role will require technical leadership in multiple late-stage programs that involve activities including but not limited to: Technology Transfer, Process Validation (PPQ, CPV), Technical Support and Technical Studies in the MSAT Laboratory. A key requirement for the successful candidate will be the ability to lead tech transfer activities for new products and previous experience in this area will be required. The senior scientist will use his/her previous technical experience and process knowledge to support on-going optimization of the upstream/downstream process. The ideal candidate will be a key contact in technical troubleshooting of unit operations and leading/supporting major process investigations at the request of the business. The scope of this role will also include designing and executing laboratory experiments in the laboratory to support process characterisation and late-stage process improvements/development activities. The candidate may be required to support both upstream and downstream areas as needed and in line with areas of expertise.
Organization Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.
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 Lead.
Your Responsibilities:
- GMP Commercial/Clinical manufacturing experience in a mammalian Cell culture/purification setting (perfusion or fed batch) operations and associated requirements.
- Act as an SME for Upstream/Downstream, including technology transfer, process validation, trouble shooting and investigation.
- Lead risk assessments in support of New Product Initiation for transferring new products and processes.
- Provide Expertise in analytical monitoring; Viable cell density, metabolite and nutrient monitoring, protein concentration, impurity monitoring and clearance and how these relate to cell culture/downstream performance and product quality.
- Author or review and approve process validation strategies, protocols and reports.
- Coaching of fellow process engineer/scientist and manufacturing personnel to increase technical knowledge of critical process steps and develop plans to build competencies and expertise.
- Support and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.
- Performs intermediate level of statistical data analysis with the ability to recognize trends and areas where more analysis should be performed. Performs statistical data analysis, charting, linear regression analysis.
- During the start-up phase of the facility this position will also provide support in building the MSAT function in Dundalk, including documentation generation and qualification of the MSAT laboratory equipment.
- Designs Experiments for execution of lab studies/analytical work with a high level of autonomy.
- Support Health Authority audits.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Will be flexible to take on additional tasks and responsibilities at the discretion of their manager
- Will act as a role model for the MSAT function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Your Profile: The ideal candidate for this position will have the following:
Education:
- Doctorate in a biotechnology area ideally or science related discipline is preferable.
- Masters/Bachelors in biotechnology or science related discipline with additional experience will be considered.
Knowledge/Experience/Technical Competencies:
- A minimum of 6 years’ Upstream and or Downstream experience in a large-scale Biopharmaceutical facility however position will be commiserate with experience.
- Thorough knowledge of Upstream and/or Downstream Processes and current Good Manufacturing Practices (cGMP).
- Previous experience in leading new product technology transfers into a clinical/commercial facility.
- Experience of authoring and developing process validation strategies, protocols and reports.
- Working laboratory experience within upstream and downstream is ideal however, experience in either
- functional area will be considered:
- Upstream: Hands-on experience in aseptic Techniques, running of small-scale bioreactors (mammalian or microbial cells).
- Downstream process: Hands-on experience in downstream unit operations such as chromatography, ultrafiltration/diafiltration, virus filtration etc.
- Analytical: Working knowledge of general protein characterization assays, e.g. gel based, chromatographic, and immuno-affinity based assays.
Personal skills:
- Excellent focus and attention to detail.
- Problem solving capabilities.
- Ability to work independently and as part of a cross functional collaborative team to achieve mutual goals.
- Good presentation skills, teamwork and ability to interact effectively with internal and external project teams,
- including customer communications.
- Excellent communication skills.
- Excellent cross functional collaboration and teamwork.
Other requirements:
- Must be willing to travel as required to fulfil the responsibilities of the position.
- Experience in statistical data analysis and manufacturing Continued Process Verification (CPV)
Closing Date for Applications: Friday 1st August 2025
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - 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 or contact us via [email protected] WuXi Biologics is an equal opportunities employer.
