Process Development Scientist
Reports to TBD
Vyriad is looking for a motivated and self-driven scientist to join our team. The Process Development Scientist is responsible for researching and developing new production processes for existing drug product (Voyager-V1) and pipeline assets, as well as modifying existing manufacturing systems to improve overall efficiency towards commercialization.
- Establish and implement process improvement plans (production, stability, formulation) with staff members.
- Author protocols, reports, risk assessments, SOPs, and batch record worksheets.
- Serve as the point of contact from the Process Development team for product/process support for technology transfers and ongoing cGMP drug product manufacturing.
- Use technical experience to troubleshoot issues with drug substance/product processing technologies and equipment.
- Serve as a subject matter expert to support manufacturing operations.
- Drive continuous improvement in our cGMP process through technological innovation and application of experimental findings.
- Lead functional and cross functional teams to achieve company goals.
- Keep up to date with current technologies and trends in drug product processing.
- Additional duties or responsibilities as assigned by supervisor.
- Advanced degree (Ph.D. and/or graduate degree) in an engineering field or 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 in single-use manufacturing technologies, conducting process characterization, analysis and development with minimal supervision and aseptic manufacturing processes in ISO 5, 6 and 7 environments is required.
Experience and Skill Requirements
- Knowledge and experience in FDA current Good Manufacturing Practices 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.
- Demonstrated capacity 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.