Analytical Operations Scientist
GSK
2 hours ago
On-site
King of Prussia, PA
Operations
This role is responsible for the manufacture of biopharmaceutical analytical reference materials and supports the R&D biopharmaceutical critical reagents program in line with regulatory and business requirements.
Responsibilities:
- Manage the manufacture of analytical reference materials using automated and manual filling instrumentation.
- Collaborate with GSK R&D and GSC analytical groups to manage manufacturing details and scheduling for reference material and reagent fills.
- Record and archive manufacturing details to comply with GSK and regulatory requirements.
- Maintain instrument and inventory of materials required to perform filling operations.
- Contribute to GSK’s overall critical reagent strategy for biopharmaceutical projects.
- Ship and receive biopharmaceutical critical reagents and RM to support R&D, commercial, and contract testing labs.
- Prepare and support internal quality and external regulatory inspections.
- Support DDS Leadership by participating in activities that promote an organizational culture aligned with GSK Values and Expectations.
- Adopt data and digital tools to drive continuous improvement and deliver simplified, efficient business processes.
- Support the large molecule stability team with stability protocol and data management, as needed.
Basic Qualifications:
- Bachelor of Science in Chemistry, Biology, or a related scientific discipline and 2+ years of experience in a directly related discipline.
- 2+ years of experience in a project team or directly related discipline.
Preferred Qualifications:
- Experience operating automated liquid systems (e.g., Hamilton).
- Awareness of protein stability and assays such as CGE, cIEF, HPLC, and functional assays.
- Awareness of cGMP and regulatory requirements for the development and commercialization of biopharmaceuticals.
- Excellent written and verbal communication skills.
- Excellent organization skills and ability to handle multiple priorities.
Application instructions:
- If you require an accommodation or other assistance to apply for a job, contact Recruitment Staff at usrecruitment.adjustments@gsk.com.
Responsibilities:
- Manage the manufacture of analytical reference materials using automated and manual filling instrumentation.
- Collaborate with GSK R&D and GSC analytical groups to manage manufacturing details and scheduling for reference material and reagent fills.
- Record and archive manufacturing details to comply with GSK and regulatory requirements.
- Maintain instrument and inventory of materials required to perform filling operations.
- Contribute to GSK’s overall critical reagent strategy for biopharmaceutical projects.
- Ship and receive biopharmaceutical critical reagents and RM to support R&D, commercial, and contract testing labs.
- Prepare and support internal quality and external regulatory inspections.
- Support DDS Leadership by participating in activities that promote an organizational culture aligned with GSK Values and Expectations.
- Adopt data and digital tools to drive continuous improvement and deliver simplified, efficient business processes.
- Support the large molecule stability team with stability protocol and data management, as needed.
Basic Qualifications:
- Bachelor of Science in Chemistry, Biology, or a related scientific discipline and 2+ years of experience in a directly related discipline.
- 2+ years of experience in a project team or directly related discipline.
Preferred Qualifications:
- Experience operating automated liquid systems (e.g., Hamilton).
- Awareness of protein stability and assays such as CGE, cIEF, HPLC, and functional assays.
- Awareness of cGMP and regulatory requirements for the development and commercialization of biopharmaceuticals.
- Excellent written and verbal communication skills.
- Excellent organization skills and ability to handle multiple priorities.
Application instructions:
- If you require an accommodation or other assistance to apply for a job, contact Recruitment Staff at usrecruitment.adjustments@gsk.com.