Data Reviewer, Analytical Chemistry
Solvias, Morrisville, NC, United States
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
Perform data review for contract services projects, including GMP testing for qualification/validation, release, and routine stability studies for different modalities.
Evaluate laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
Communicate with laboratory staff to proactively address the quality of laboratory documentation.
Understand principles of the technologies in scope for data review.
Verify that calculations and documented information are correct, complete, and accurate in accordance with guiding documents and internal procedures.
Maintain and update knowledge of relevant instrumentation and cGMP standards.
Contribute to review related feedback, including review group needs, to functional management. Work with functional management to improve review cycle time.
Familiar with analytical techniques such as UPLC/HPLC, CE‑SDS, LC‑MS, iciEF, compendial testing, etc. Familiarity with CDS system (Empower/Chromeleon) as well as LabWare Electronic Laboratory Notebook functionalities.
Essential Job Functions
Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
Have background in biopharmaceutical analytical testing and understand cGMP standards.
Ability to adaptively adjust to changing priorities and customer needs.
Experience reviewing operational SOPs, technical documents, protocols, and reports.
Work collaboratively with cross-functional teams.
Able to work effectively in a fast‑paced environment.
Excellent communication, technical, organizational, and interpersonal skills are essential.
Qualifications
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.
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.
Reporting Structure
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.
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Critical Performance Areas
Perform data review for contract services projects, including GMP testing for qualification/validation, release, and routine stability studies for different modalities.
Evaluate laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
Communicate with laboratory staff to proactively address the quality of laboratory documentation.
Understand principles of the technologies in scope for data review.
Verify that calculations and documented information are correct, complete, and accurate in accordance with guiding documents and internal procedures.
Maintain and update knowledge of relevant instrumentation and cGMP standards.
Contribute to review related feedback, including review group needs, to functional management. Work with functional management to improve review cycle time.
Familiar with analytical techniques such as UPLC/HPLC, CE‑SDS, LC‑MS, iciEF, compendial testing, etc. Familiarity with CDS system (Empower/Chromeleon) as well as LabWare Electronic Laboratory Notebook functionalities.
Essential Job Functions
Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
Have background in biopharmaceutical analytical testing and understand cGMP standards.
Ability to adaptively adjust to changing priorities and customer needs.
Experience reviewing operational SOPs, technical documents, protocols, and reports.
Work collaboratively with cross-functional teams.
Able to work effectively in a fast‑paced environment.
Excellent communication, technical, organizational, and interpersonal skills are essential.
Qualifications
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.
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.
Reporting Structure
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.
#J-18808-Ljbffr