Septerna
Biotechnology
SeniorManager,AnalyticalQualityControl
“Senior Manager, Analytical Quality Control at Septerna. Skills: Analytical Quality Control, Small molecule programs, CDMO management. Manage analytical development activities. Manage quality control activities”
Industry & Context.
Critical thinking; Root cause analysis
Up to 10% travel
What They're Looking For.
Must Have
10 years relevant industry experience, 8 years relevant industry experience, 5 years relevant industry experience, Demonstrated execution of QC activities, Demonstrated experience managing analytical method development, Demonstrated experience phase appropriate method qualification/validation, Demonstrated experience release and stability testing, Knowledge of analytical techniques for small molecules, Knowledge of analytical techniques for oral solid dose products, Proficient in IR, Proficient in UPLC/HPLC, Proficient in KF, Proficient in GC, Proficient in dissolution, Proficient in microbial limit tests, Proven proficiency working with quality systems, Experience applying compendial standards, Experience applying regulatory authority guidance, Demonstrated experience managing external partners, Demonstrated experience collaborating with external partners, Exhibited organizational skills, Exhibited critical thinking skills, Attention to detail, Excellent interpersonal skills, Excellent communication skills, Effective management of multiple priorities
Nice to Have
MS degree, PhD degree
What You'll Do.
Manage analytical development activities
Manage quality control activities
Provide QC oversight of analytical testing
Provide QC oversight of stability studies
Perform in-depth reviews of raw analytical data
Ensure data integrity
Ensure compliance with specifications
Establish processes for tracking CDMO testing
Establish processes for trending CDMO testing
Manage reference standards
Manage reference materials
Author stability summary reports
Review stability summary reports
Support development of quality system
Maintain compliance with quality system
Author standard operating procedures
Review standard operating procedures
Author work instructions
Review work instructions
Review analytical method validation protocols
Review analytical method validation reports
Review change controls
Review corrective actions
Review preventative actions
Review investigations
Author data in CMC sections
Review data in CMC sections
Verify data in CMC sections
Support evaluation of CDMOs
Support selection of CDMOs
Support management of CDMOs
Collaborate with Analytical Development
Collaborate with Process Chemistry
Collaborate with Pharmaceutical Development
Collaborate with Supply Chain Management
Collaborate with Quality
Collaborate with Regulatory
Collaborate with DMPK
Collaborate with Toxicology
Collaborate with Clinical Pharmacology
How You'll Work.
Team & Collaboration
Cross functional teams; External partners
Communication Scope
Present data
Process & Methodology
Change Management
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