Senior Specialist, Quality Control (Contract)

Position Summary

Orbital Therapeutics is seeking a skilled QC specialist with GMP experience to join the Quality Control team to support testing of novel RNA therapeutics. The successful candidate will help oversee external QC activities and analyze internal routine testing samples.

Responsibilities:

• The person will serve as a Subject Matter Expert (SME) in the quality control group and will work along with analytical development team on method transfers from internal analytical team to external CDMO QC group
• The workstreams include technical GMP lead for oversight of external release and stability testing, method transfer troubleshooting, assisting in critical reagent management, execution of technical protocols
• Oversight of method qualification, validation at CDMO QC laboratories
• Support stability data analysis along with stability document reviews
• Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors, if needed
• Work with QA group on datasheet review, QC investigation, out of specification (OOS), CAPA, Change Controls, and/or Deviation reports
• Independently develop, author, revise, and execute SOPs, protocols, reports, and other related documents
• Perform internal stability testing for RNA related testing samples and formulated drug product samples, including compendial methods along with biophysical testing such as particle size, LNP encapsulation, etc.
• Support routine analytical testing for research program needs, such as with chromatography-based methods (HPLC) and/or biochemical assays such as ELISA assay
• Prepare the data packet for review and peer-review the data

Qualifications:

• Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 5+ years relevant experience
• Past experience with quality control, preferably with focus on stability
• Hands-on experience on with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required
• Good understanding with cGMP, GDP and GLP regulations and guidelines
• General experience in data analysis and statistical evaluation/data trending
• Scientific knowledge and direct experience with analytical method transfer processes
• Advanced technical writing skills and problem-solving ability
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
• Communicate effectively with peers, and demonstrate collaboration across different functional groups
• Detail-oriented in assay execution and documentation