WuXi Biologics
MSAT Scientist
WuXi Biologics, Dundalk, Maryland, United States, 21222
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 includes 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.
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 are one of the world's top three contract development and manufacturing companies for biopharmaceuticals, providing 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. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.
Department Description
As MSAT 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’ll be reporting to the MSAT Associate Director.
Your Responsibilities
Act as an SME for Upstream/Downstream, including technology transfer, process validation, troubleshooting, and investigation.
GMP Commercial/Clinical manufacturing experience in a mammalian cell culture/purification setting (perfusion or fed batch) operations and associated requirements.
Author or review and approve process validation strategies, protocols, and reports.
Perform tasks for execution of simple lab studies/analytical work with an elevated 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.
During the start-up phase of the facility, 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 and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.
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.
Minimum of Bachelor of Science degree in biotechnology area ideally or science related discipline.
Knowledge/Experience
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 of authoring process validation protocols and reports.
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.
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 communication skills.
Excellent cross-functional collaboration.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. 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!
#J-18808-Ljbffr
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 includes 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.
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 are one of the world's top three contract development and manufacturing companies for biopharmaceuticals, providing 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. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.
Department Description
As MSAT 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’ll be reporting to the MSAT Associate Director.
Your Responsibilities
Act as an SME for Upstream/Downstream, including technology transfer, process validation, troubleshooting, and investigation.
GMP Commercial/Clinical manufacturing experience in a mammalian cell culture/purification setting (perfusion or fed batch) operations and associated requirements.
Author or review and approve process validation strategies, protocols, and reports.
Perform tasks for execution of simple lab studies/analytical work with an elevated 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.
During the start-up phase of the facility, 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 and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.
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.
Minimum of Bachelor of Science degree in biotechnology area ideally or science related discipline.
Knowledge/Experience
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 of authoring process validation protocols and reports.
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.
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 communication skills.
Excellent cross-functional collaboration.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. 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!
#J-18808-Ljbffr