Associate Director, Analytical Development & Quality Control at NextCure Inc

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 Associate Director, Analytical Development & Quality Control to join the 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 Associate Director is a member in the Analytical Development and Quality Control (AD/QC) Group. They will be a key technical expert and will be responsible for managing the quality control processes for various products from preclinical through early and late clinical phases, ensuring their integrity and compliance to the CGMPs. This includes managing, implementing and review of QC protocols, QC SOPs, release assays (DS and DP), reference standard qualification and stability programs for development and GMP assays, ensuring compliance with regulatory requirements. The Associate Director may also oversee CDMO documents related to quality control. They will also be involved in addressing deviations, CAPAs, OOSs and OOTs as needed. The role involves close collaboration with process development staff to coordinate development and GMP manufacturing sampling plans and testing, participation in GMP manufacturing, sampling and testing activities as required, and preparing updates, reports, data summary presentations to technical staff and executive team members. Additionally, this role requires building collaborative relationships with Research team and QA, staying updated with industry trends and regulatory requirements, leading the team in decision-making and problem-solving processes and being able to achieve department goals.

SKILLS & ABILITIES

• Provide leadership and oversee development and GMP QC testing and manage internal stability program. Represent AD/QC in cross-functional teams (Analytical Development, Upstream, Downstream, QA, Research and Manufacturing departments). Ensure leadership from AD/QC to meet process development and product release timelines. Manage stability programs to ensure timely testing, real time trending and generation of stability reports in a fully CGMP-compliant manner.
• Strong background and understanding of various analytical methods such as SEC-HPLC, RP-HPLC, IEX, CE-SDS, cIEF, compendial assays as well as ELISA, cell-based assays and qPCR
• Routinely execute and review analytical assay executions (e.g., CE-SDS, cIEF, SEC-HPLC, ELISA, compendial assays, etc.) for drug substance and drug product release and stability
• Author/review/approve various documents including SOPs, Certificate of Analysis (CoA), technical reports, stability reports for regulatory filings, change controls, deviations, CAPAs, OOSs, OOTs
• Serve as QC representative in material review board meetings
• Oversee and manage contract testing laboratories to meet testing needs for assays that are outsourced
• Work closely with QA Team for closing out CoAs, deviations, CAPAs, OOSs, SOPs, qualification protocols and reports
• Knowledge in Statistical Analysis, CGMP, CFR, USP and GDP
• Generate purchase orders and procure supplies, as needed
• Strong working knowledge of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing
• Participate in technical meetings, present Quality Control data to inspectors/auditors, and support IND/IMPD filings
• Ensure QC laboratories, and operations are CGMP compliant. This includes but is not limited to overseeing of analytical equipment qualification, maintenance, and calibration programs, ensuring that QC procedures, practices and analytical methods are in compliance with the applicable compendial and regulatory requirements
• Strong ability to take on various types of tasks, demonstrating flexibility and willingness to accept completely outside-the-box assignments are key success factors for this role. The candidate must be willing to wear many hats in a learning-focused small company environment
• Hands-on involvement with assay execution, training, instrument upkeep and laboratory organization is needed
• Ability to work successfully in cross-functional teams and represent at various internal and external meetings
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
• This role will have supervisory responsibilities
• Ability to report to the Beltsville, Maryland office location on a full-time daily basis

EXPERIENCE

• BS with 10+ years of hands-on industry experience in Quality Control authoring, reviewing and approving various release, stability of drug substance and drug product assays in development and GMP setting. Support upstream and downstream GMP manufacturing activities as needed.
• MS with 8+ years of hands-on industry experience in Quality Control authoring, reviewing and approving various release, stability of drug substance and drug product assays in development and GMP setting. Support upstream and downstream GMP manufacturing activities as needed

EDUCATION

• Bachelor’s degree (BS) in the life sciences, biochemistry, or related field is required
• Master’s degree (MS) in life science, biochemistry or related field is preferred