2 days ago Be among the first 25 applicants
Direct message the job poster from WuXi Biologics
Talent Acquisition Business Partner Wuxi Biologics, Dundalk
MSAT Scientist
As MSAT Scientist you will be responsible for execution of laboratory‑based studies or execution of assays with minimal supervisory direction and/or execution of technology transfer and validation activities. You will be expected to be a subject matter expert (SME) in Upstream/Downstream/Analytical techniques. Key responsibilities of the MSAT Scientist include executing process optimization studies on lab scale to support manufacturing efficiencies, satellite runs, new product introduction and process validation activities. The position will provide technical leadership for biologics manufacturing, support validation activities, optimization and troubleshooting of processes including supporting laboratory scale studies. The candidate may be required to support both upstream and downstream areas as needed and in line with areas of expertise.
Department Description
As MSAT Scientist you will 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
* 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.
* Author or review and approve process validation strategies, protocols and reports.
* Perform tasks for execution of simple lab studies/analytical work with a high level of autonomy, and more complex studies/analytical work with supervisory input and in accordance with study protocols or SOPs.
* Draft study protocols and reports independently with supervisor/ peer review.
* Perform intermediate level of statistical data analysis with the ability to recognize trends and areas where more analysis should be performed. Perform basic 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.
* Lead risk assessments in support of new product initiation for transferring new products and processes.
* Support Health Authority audits.
* Support and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.
* 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 organization in adherence to the WuXi corporate core values and PROUD culture.
Your Profile
Education
* Doctorate in a biotechnology area or science related discipline is preferable.
* Minimum of Bachelor of Science degree in biotechnology area or science related discipline.
Knowledge/Experience
* Minimum of 2 years’ Upstream and/or Downstream experience in a large‑scale Biopharmaceutical facility; however position will be commensurate with experience.
* Thorough knowledge of Upstream and/or Downstream Processes and current Good Manufacturing Practices (cGMP).
* Previous experience in new product technology transfers into a clinical/commercial facility.
* Experience authoring process validation 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 bioreactor (mammalian or microbial cells) is ideal.
* 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 is ideal.
* Working experience with protocol, report writing and data analysis is required.
* Technical experience working technology transfer and process validation activities.
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 cross‑functional collaboration.
Onerous Requirements
* Must be willing to travel as required internationally to fulfil the responsibilities of the position.
Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr