Senior Manager of Quality Control

NextCure is a clinical-stage biopharmaceutical company located in Beltsville, Maryland, focused on the discovery and development of first-in-class immunomedicines for the treatment of cancer and other diseases. We are committed to professional development in the context of learning, managing, and developing our employees. We create a unique environment for our employees, providing exposure to various facets of our operations to cultivate interdisciplinary career growth and development.

NextCure is seeking an experienced and highly motivated Senior Manager of Quality Control to join our Analytical Development and Quality Control (AD/QC) team. This is an on-site position located in Beltsville, Maryland. Applicants must be able to report to the Beltsville office on a daily basis.

JOB SUMMARY

The Senior Manager of Quality Control reviews all development and GMP assays executions, support execution of assays, address deviations and out-of-specification results. This position is involved in a wide-range of analytical development and quality control activities related to clinical products spanning assay development, product characterization, product release assays, stability studies, and support of pre-clinical studies and process development. The Senior Manager has a deep interest in contributing to the delivery of biopharmaceutical therapies to patients.

REQUIRED SKILLS & ABILITIES

• Serve as subject matter expert for GMP analytical testing and assist stability programs.
• Routinely review analytical assay executions (e.g., SDS-PAGE, Bioanalyzer/cIEF, SEC-HPLC, ELISA, Octet, etc.) for drug substance and drug product release and stability.
• Author/review/approve various documents including SOPs, Certificate of Analysis, technical reports, stability reports for regulatory filings, deviations, CAPAs, OOSs, stability protocols/documentation.
• Serve as QC representative in material review board meetings.
• Experience with the CMO assay review process.
• Maintain laboratories and equipment in good working order as the primary contact person from Quality Control
• Generate purchase orders and procure supplies, as needed.
• Participate in technical meetings, present Quality Control data to inspectors/auditors, and support IND/IMPD filings.
• Oversee GMP Manufacturing activities as needed.

REQUIRED EXPERIENCE

• Prior experience working directly for a Biotechnology company within a similar capacity.
• 5+ years of industry experience overseeing a wide array of analytical assays in a clinical GMP setting.
• Have experience analytical methods including SEC, CGE, cIEF, ELISA, and Octet.
• Previous experience with LIMS is a plus.
• Ability to work a full-time schedule in-office on a daily basis in Beltsville, Maryland.

REQUIRED EDUCATION

• BS/MS/PhD in Pharmaceutical Chemistry and/or Biochemistry or a related technical field.