Become a vital member of a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. We're committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
- Lead and assist with numerous CSV-focused tasks.
- Perform master batch record review and execute batch record review.
- Support activities for dispositioning clinical and commercial bulk drug products and finished drug products.
- Support the change management process, ensuring compliance with cGMP.
- Assist in quality investigation of manufacturing/packaging deviations.
- Assist in GMP audits, as required.
- Assist in supplier qualification and reassessment activities.
- Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
- Review and update GMP related SOPs and policies
- Participate in projects that support continuous improvement efforts.
- CMO oversight of packaging contractors. Support manufacturing and packaging validation activities as well as commercial launch activities.
- Participate in interactions with external service providers, as applicable.
*Some travel is required, domestic and international.
Qualifications & Expertise
- 4+ years of relevant experience in quality assurance within Biotech/Life Sciences
- Bachelor's degree or higher
- Thorough knowledge of IQ/OQ/PQ and other validation processes, with a particular focus on CSV background
- Working knowledge and understanding of ICH, FDA, and EU regulations
- Strong experience in GMP environment
- Excellent communication skills, both oral and written; excellent interpersonal skills
- A collaborative mindset is essential