Staff Scientist (Senior Manager), Quality Control & Analytical Development
About Glyphic:
At Glyphic Biotechnologies, we plan to create the protein revolution for which scientists and researchers have been waiting. We are developing a massively parallel, single-molecule proteome sequencing platform that will transform life science discovery and usher in a new era of insights into human biology and disease. To date, we have raised >$50M from venture partners and non-dilutive grant funding to achieve our vision of next generation proteome sequencing.
What we are looking for in you:
Glyphic is seeking an experienced quality and analytical development leader who will report to the Chief Operating Officer and anchor a newly formed Quality Control & Analytical Development team focused on establishing an internal core facility to centralize Glyphic’s current analytical development activities while building out a phase appropriate Quality Control program in support of a commercial launch. This will be a unique opportunity to design and implement new analytical processes, build out a dedicated lab, and see your contributions directly translate into the creation and commercialization of advanced proteomic and genomic analysis platforms.
The ideal candidate will have a strong background in analytical chemistry, specifically in the operation and troubleshooting of LCMS and HPLC systems for the characterization of oligonucleotides, peptides, and small molecules, and the productization of complex life science platforms or instruments. Experience with method development, data interpretation, and regulatory compliance is highly desirable. This position requires the candidate to be hands-on in procuring and operating advanced analytical instrumentation while working with a cross-disciplinary team of chemists, biologists, engineers, and bio-informaticians to rapidly deliver consistent results and insights that accelerate the development cycle.
Responsibilities:
- Execute analytical testing using LCMS, HPLC, and CE instruments for protein and nucleic acid characterization and purity assessment.
- Establish and operate a new QC & AD core to support instrument and assay development
- Develop, optimize, and validate analytical methods to characterize novel protein sequencing instrumentation and production processes
- Implement and oversee phase-appropriate in-line quality control processes and monitoring programs
- Establish and perform QC testing for raw materials and finished products
- Support investigations for out-of-specification results, including root cause analysis, corrective action implementation, and detailed investigation reports.
- Support stability studies and comparability programs
- Establish and maintain a phase-appropriate environmental monitoring program
- Generate quality metrics reports analyzing testing volumes, turnaround times, and trends in analytical results.
- Manage QC sample storage, retention, and disposal according to safety protocols, particularly for hazardous materials.
- Author and review study protocols and reports as well as documentation to comply with regulatory and audit requirements
Required Competencies:
- Advanced degree in Chemistry, Analytical Chemistry, Biochemistry, or related field
- 8+ years in analytical development or protein characterization with quality control experience
- Proven track record operating and maintaining LCMS, HPLC, CE systems independently
- Deep understanding of separation science, mass spectrometry, spectrophotometry, electrophoresis
- Proficiency in statistical analysis and report generation
- Experience with analytical method development, optimization, validation
- Demonstrated complex troubleshooting (instrument, method, sample prep issues)
- Strong technical writing (SOPs, reports, investigations)
- Proven ability to manage multiple time-sensitive projects supporting cross-functional stakeholders
Preferred Competencies:
- Proficiency in Agilent BioConfirm software
- Proficiency in Atlassian tools for project management
Benefits and Perks:
- Employee Stock Option Plan
- 100% Health Plan Coverage for Employees & Dependents (Medical, Dental, & Vision)
- Employer Retirement Contributions to 401(k)
- Generous Paid Time Off
- Paid Maternity and Paternity Leave
- Health & Wellbeing Program
- Office Snacks and Beverages
- Regular Team Bonding Activities
We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Glyphic Biotechnologies are considered without regard to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.