ZipRecruiter
Senior Scientist, Biophysical Characterization (BPC)
ZipRecruiter, Morrisville, North Carolina, United States, 27560
Position Overview
Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Senior Scientist position will be in the BPC 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
Develop, validate, and transfer analytical methods for the analysis of drugs using analytical techniques according to GMP requirements. Perform quality lab activities according to assigned schedule. Collaborate with the director and team lead to train, develop, and coordinate daily laboratory tasks for the team. 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. Essential Job Functions
Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs). Prepare and review lab notebooks, protocols, and reports. Investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events. Train peers and analysts in the team as needed. SME in LC-MS, HPLC, and UPLC techniques. 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. Requirements
PhD with 5+ years relevant experience, M.S. Life Sciences with 8+ years relevant experience, or B.A/B.S. with 10+ years relevant experience. Experience working in GMP or GLP environment. Experience in method development, qualification, and validation of LC/MS assays, particularly large molecule analysis. Experience communicating with clients is a plus. Previous supervisory experience is a plus. Other Desired Skills/Abilities
Site or laboratory startup experience is a plus. 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. Familiarity with Quality and laboratory systems such as Labware LIMS, MasterControl, Empower, Chromeleon is a plus. Ion Trap LC-MS experience is . 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. Estimated travel is up to 10% annually as applicable.
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Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Senior Scientist position will be in the BPC 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
Develop, validate, and transfer analytical methods for the analysis of drugs using analytical techniques according to GMP requirements. Perform quality lab activities according to assigned schedule. Collaborate with the director and team lead to train, develop, and coordinate daily laboratory tasks for the team. 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. Essential Job Functions
Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs). Prepare and review lab notebooks, protocols, and reports. Investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events. Train peers and analysts in the team as needed. SME in LC-MS, HPLC, and UPLC techniques. 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. Requirements
PhD with 5+ years relevant experience, M.S. Life Sciences with 8+ years relevant experience, or B.A/B.S. with 10+ years relevant experience. Experience working in GMP or GLP environment. Experience in method development, qualification, and validation of LC/MS assays, particularly large molecule analysis. Experience communicating with clients is a plus. Previous supervisory experience is a plus. Other Desired Skills/Abilities
Site or laboratory startup experience is a plus. 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. Familiarity with Quality and laboratory systems such as Labware LIMS, MasterControl, Empower, Chromeleon is a plus. Ion Trap LC-MS experience is . 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. Estimated travel is up to 10% annually as applicable.
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