Quality Control and Analytical Assay Development Manager
Reports to Director of Quality
Vyriad is looking for a motivated and self-driven scientist to join our team. The Quality Control and Analytical Assay Development Manager (QC/AD) is responsible for validating and performing analytical methods essential for quality control and release of drug product, as well as development and optimization of new analytical methods, and their validation, thus ensuring that manufacturing processes and products meet quality specifications.
- Optimize and validate test methods for cGMP manufacturing and process development.
- Write validation protocols and reports for test methods.
- Perform and maintain test systems for cGMP manufacturing.
- Perform and manage assays related to in-production and post-production product quality.
- Perform and manage qualification/validation processes to maintain analytic validity of test methods.
- Monitor aseptic manufacturing suites for contamination or manage outsourced vendor services.
- Maintain and monitor equipment and instruments, diagnose and troubleshoots minor issues with laboratory instruments and equipment.
- Keep up to date with current technologies and trends in drug product analysis.
- Other duties and responsibilities as assigned by supervisor.
- Advanced degree (Ph.D. and/or graduate degree) in a science related field with 5+ years of related work experience or a bachelor’s degree in a science related field with 8+ years of related work experience. All candidates must have a minimum 4 years working in biologics drug product quality control with analytical method development experience.
- Personnel management experience is required.
Experience and Skill Requirements
- Knowledge and experience in FDA cGMP for product manufacturing and testing is required. Experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional communication (written, verbal, and listening) skills are required.
- Strong orientation for details and ability to work independently and productively with minimal direction, and routinely exercises initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role.
- Ability to write and comprehend complex protocols and reports, programs and situations.
- Ability to exercise good judgment while under pressure and tight deadlines. Strong coping skills are required.
- Must be flexible in adapting to a variety of responsibilities, work assignments and priorities.