Position Overview
Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Senior Scientist position will be in the AC team supporting analytical activities related to large molecules. This position is a team member in the Large Molecule & Advance Therapy Medicinal Products (ATMP) Services in a Good Manufacturing Practices (GMP) laboratory environment.
Critical Performance Areas
Execute routine testing for the analysis of drugs using analytical techniques according to GMP requirements.
Perform method verifications and method transfers to support project and testing needs.
Perform quality lab activities according to assigned schedule.
Generate, interpret data, and troubleshoot assays as needed.
Manage multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients.
Familiar with analytical techniques such as UPLC/HPLC, CE-SDS, LC-MS, iciEF, compendial testing etc.
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards
Requirements
- M.S. Life Sciences with 2+ years of relevant experience, or equivalent combination of education and relevant experience.
- Experience working in GMP or GLP environment.
- Experience in method development, qualification, and validation of analytical chemistry assays, particularly large molecule analysis.
Experience communicating with clients is a plus. Previous supervisory experience is a plus.
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Other Desired Skills/Abilities
- Experience working in a contract (CRO) environment.
- Excellent organizational skills, ability to work independently and collaboratively in a team environment.
- Strong written and verbal communication skills.
- Prior Chromeleon/Empower experience is a plus.
Prior experience with ELN is preferred, not necessary
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Reporting Structure
This job reports to:
Team Lead, Analytical Chemistry
NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
Requirements
- M.S. Life Sciences with 2+ years of relevant experience, or equivalent combination of education and relevant experience.
- Experience working in GMP or GLP environment.
- Experience in method development, qualification, and validation of analytical chemistry assays, particularly large molecule analysis.
Experience communicating with clients is a plus. Previous supervisory experience is a plus.
-
Other Desired Skills/Abilities
- Experience working in a contract (CRO) environment.
- Excellent organizational skills, ability to work independently and collaboratively in a team environment.
- Strong written and verbal communication skills.
- Prior Chromeleon/Empower experience is a plus.
Prior experience with ELN is preferred, not necessary
-
Reporting Structure
This job reports to:
Team Lead, Analytical Chemistry
NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
Essential Job Functions
- Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
- Train peers and analysts in the team as needed.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Responsible for maintaining inventory, ordering laboratory supplies, and instrument maintenance.
- Work collaboratively with cross-functional teams and customers.
- Able to work effectively in a fast-paced environment.
- Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
- Excellent communication, technical, organizational, and interpersonal skills are essential.
Essential Job Functions
- Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
- Train peers and analysts in the team as needed.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Responsible for maintaining inventory, ordering laboratory supplies, and instrument maintenance.
- Work collaboratively with cross-functional teams and customers.
- Able to work effectively in a fast-paced environment.
- Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
- Excellent communication, technical, organizational, and interpersonal skills are essential.
