AltPep Corporation is a biomedical start-up located in Seattle, Washington, with a breakthrough approach for diagnosing and treating some of the world’s most intractable conditions: amyloid diseases. Our lead programs are focused on Alzheimer’s Disease and Parkinson’s Disease.
We are seeking a highly motivated and experienced Quality Control (QC) Director. This key position will lead the Quality Control function for AltPep’s diagnostics and therapeutic programs, which are currently in early-stage development.
- Drive strategic decisions, implement processes and manage activities related to QC systems. Build roadmap for the QC function through sound scientific and regulatory knowledge and experience.
- Work cross-functionally with internal and/or external partners (i.e. CDMOs) to write technical documentation for incoming materials, in-process and finished products, and post-launch monitoring. This includes product specifications, SOPs, test-methods, qualification protocols/reports, and method transfer protocols/reports, as required.
- Oversee stability studies and shelf-life programs including authoring shelf-life reports.
- Serve as QC Subject Matter Expert (SME) for analytical methods, sampling, troubleshooting, investigations, deviations, non-conformances, etc.
- Work with other SMEs (internal and/or external) to review and author application sections of regulatory submissions, and to provide support for information requests, as required.
- Work with Quality Assurance and Regulatory to establish and sustain an effective and efficient quality management system.
Education and Experience
- in chemistry, biochemistry, pharmaceutical sciences, bioengineering, or related discipline
- At least 5 years QC management experience and 10+ years industry experience in analytical development and/or quality control (CDMO experience preferred).
- In depth knowledge of therapeutics and/or diagnostics raw material release and stability testing, methods, and quality systems.
- Strong working knowledge of CLIA, cGMP, GLP, and FDA guidance and regulations related to diagnostics and/or therapeutics.
Required Skills and Abilities
- Ability to work cross-functionally, both internally and externally, to advance company goals and initiatives.
- Strong technical acumen, including proficiency at determining the root cause of a problem, and working with others to implement solutions.
- Ability to articulate information in a logical and clear manner to internal and external teams.
- Strong technical writing skills.
- Comfortable in a fast-paced small company environment and able to balance workload based upon changing priorities.