Director, Analytical Development (Flow Cytometry & Method Validation)
Orca Bio · Sacramento, CA · 5 days ago
On-siteManagementFull-time
About the role
The Director, Analytical Development will lead the flow cytometry and method validation initiatives within the organization. This role is responsible for ensuring the accuracy and reliability of analytical methods used in drug development.
Responsibilities
- Oversee the development and validation of flow cytometry-based assays for drug discovery and development.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
- Develop and maintain robust quality control procedures for analytical methods.
- Provide technical guidance and mentorship to junior staff members.
- Stay current with advancements in flow cytometry and method validation techniques.
Requirements
- A PhD in Chemistry, Biochemistry, Molecular Biology, or a related field.
- At least 10 years of experience in analytical development, preferably in pharmaceuticals or biotechnology.
- Proven track record in leading and managing analytical development projects.
- Experience with FDA guidelines and other relevant regulatory requirements.
- Strong leadership skills and ability to manage multiple projects simultaneously.
Qualifications
- Expertise in flow cytometry and method validation techniques.
- Knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Ability to work independently and as part of a team.
- Excellent communication and presentation skills.
Skills
- Fluency in statistical analysis software (e.g., R, Python).
- Experience with laboratory informatics systems.
- Strong problem-solving and critical thinking skills.
Benefits
- Competitive salary commensurate with experience.
- Flexible working hours.
- Health insurance coverage.
- Retirement plan options.
- Professional development opportunities.
Pay
$150,000 - $180,000 annually.
Schedule
Monday through Friday, 9:00 AM - 5:00 PM.