Lead QC Environmental Monitoring Analyst responsible for routine monitoring, sampling, protocol execution, SOP development, data review, investigations, and training within a cGMP environment.
Responsibilities
Perform routine environmental monitoring of classified clean rooms
Conduct utility sampling and analysis of water and steam systems
Monitor clean rooms during manufacturing operations
Perform monitoring and analysis of clean compressed air system
Write and execute protocols, experiments, and notebook studies
Requirements
High school Diploma, GED, or equivalent credential required
AS degree or BS degree in Microbiology or related scientific field preferred
Lead in vivo, ex vivo, and in vitro studies to support preclinical drug discovery and translational science at Septerna.
Compensation
The anticipated salary range for candidates who will work in South San Francisco, CA is $100,000 - $110,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Responsibilities
Design and execute in vivo pharmacology studies
Generate, analyze, and document data to establish PK/PD relationships
Collaborate to determine mechanism of action of drug candidates
Present results in lab, team, and department meetings
Perform literature searches and troubleshoot experiments
Requirements
BSc or MSc in Pharmacology, Toxicology, or related biological science
Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Compensation
The compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.
Responsibilities
Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions and System Walkdowns
Requirements
Bachelor's or Master's in a relevant science or engineering field
Line support quality engineer responsible for quality assurance in manufacturing operations, developing and implementing quality plans, protocols, and improvement projects.
Responsibilities
Develop product quality plans, documents and systems
Implement changes through change management system
Write and approve protocols and reports
Generate and approve qualification and validation protocols
Monitor progress and performance against project plan
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