- Expired: over a month ago. Applications are no longer accepted.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We view the immune system holistically and, rather than target one specific immune cell type, we focus on understanding biological pathways, the interactions of cells and the role each interaction plays in an immune response. We are focused on patients who do not respond to current therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies.
We develop products from gene cloning to final drug product focusing on production efficiency and ease of technology transfer and process operations. This “All Stream” approach integrates all aspects of development with the highest level of quality and is designed to improve outcomes by eliminating the traditional “silos” between cell line development, cell culture process development, downstream process development, formulation, analytical chemistry, and product characterization.
NextCure’s dedicated, state-of-the-art GMP manufacturing facility supports our biologics pipeline and candidates advancing into clinical development. The cleanroom space features state-of-the-art construction materials and utilizes single-use production systems. The clinical production space is designed to operate as a multi-product facility to support NextCure’s robust pipeline of first-in-class immunotherapy-based product candidates.
We are seeking a highly motivated Quality Assurance Specialist 1 and/or 2. The candidate must thrive and adapt to a fast-paced, innovative and changing environment.
- Support internal quality systems
- Assure compliance with current GXP and EU regulations
- Participate in quality audits and inspections including FDA and other regulatory agencies
- Support supplier control program including external vendor audits
- Batch record review
- Master documentation review
- Review of QC assays
- Support validation of equipment and processes, including review of new protocols as well as executed protocols and reports
- Change control review and approval
- Develop and deploy training for pertinent quality systems
- Support internal training program
- Maintain current standard operating procedures and implement new procedures as needed
- Assist with dynamic, project-based activities and system improvements
- Assist with routine QA operations (batch record review, investigations into deviations, CAPA, training/LIMS management)
- Perform root-cause analysis and other problem-solving activities to identify corrective and preventative actions
- Quality metrics tracking
- Work across all disciplines (e.g., manufacturing, clinical, regulatory, R&D, etc.) to ensure that the company maintains a state of compliance
- Collaborate with facility in creating facility procedures and other areas SOPs alignment
- Provide support to CSV systems validation and GAMP5 best practices
- Familiarize with EU guidelines and keep updates to the latest compliance requirements
Required education and experience
- Minimum of a B.S. in Biology, Chemistry, Microbiology, or related field
- Minimum 3-6 years’ experience within the biotech/pharmaceutical industry
- Prior experience with GMP procedures is required
- Good communication skills and strong attention to detail
- Willingness to acquire new skills and ability to learn quickly
- Good knowledge of quality and/or GMP principles
NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment.
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