Forge Biologics is looking to solve the problem of maintaining quality throughout the product development lifecycle by implementing quality control measures and ensuring compliance with regulations and company guidelines.
Requirements
- Knowledge of electronic lab notebook system, Benchling, documentation and training system, Quality Management System (Veeva), and equipment management system (Blue Mountain Regulatory Asset Manager).
- Experience with Electronic Quality Management Systems (EQMS) and laboratory Information Management Systems (LIMS).
- Robust understanding of regulatory requirements as they pertain to process characterization.
- Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.
- SME for quality processes and systems.
- Proven ability to perform quality reviews on documentation and processes.
- Experience in leading, mentoring, and guiding junior team members.
Responsibilities
- Work closely with process development research scientists to ensure adherence to quality standards and regulatory requirements.
- Create a phase-appropriate quality plan in collaboration with the process development team, outlining critical quality attributes, acceptance criteria and testing protocols.
- Maintain accurate and detailed documentation of all process characterization activities.
- Provide compliance oversight by ensuring adherence to relevant regulatory standards (e.g., FDA, GDP) throughout the process development and characterization phase.
- Ensure that the equipment that PD group uses is properly inspected, calibrated, and maintained to a level of quality appropriate for process characterization, and that equipment readiness is properly scheduled and documented in BMRAM.
- Ensure data used for process characterization is accurate and controlled.
- Review study protocols, and technical reports and approve documentation associated with in-process, final product, and stability testing.
Other
- Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology). Advanced degree preferred.
- Excellent communication and collaboration skills to work effectively with cross-functional teams.
- Ability to work in a confined space, such as a clean room or laboratory environment.
- Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
- Must be able to work in a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.
