Aerogen Pharma ยท 3 weeks ago
Lab Manager - Analytical Development
Foster City, CA
Full-time
Onsite
Senior Level
5+ years expAerogen Pharma is a clinical-stage specialty pharmaceutical company focused on transforming care for acute and critically ill patients. The Lab Manager will establish and maintain an analytical development laboratory to support lipid-peptide and lipid-protein formulation development, ensuring compliance with quality and regulatory standards while managing and mentoring staff.
Pharmaceuticals
Responsibilities
Lab design, establishment and operations: Establish state-of-the-art analytical development testing laboratory to provide support for lipid-peptide and lipid-protein formulation development efforts. Ensure efficient and safe lab operations
Mentorship and managing direct reports: Hire and mentor staff and manage direct reports
Analytical Methods: Provide guidance and hands on support for the design and optimization of methods for characterizing and controlling the quality the quality attributes of lipid-peptide and lipid-protein formulations
CDMO/CMO Collaboration. Ensure effective communication and coordination with our GMP partners to meet project timelines and quality expectations
Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to regulatory requirements
Cross-Functional Collaboration: Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate analytical development within overall project goals
Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing
Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends
Qualification
Required
A degree in Analytical Chemistry or related field and 10 plus years in lab operation experience is required, or a Ph.D. in the above related fields and 5 years of lab operation experience
Experience in technical writing is required
Excellent written and oral communication skills
Proficiency in analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods
Deep understanding of laboratory procedures, equipment, software, and data analysis
Effectively manage the lab budget and resources
Motivate, inspire, and lead a team of analytical chemists
Clearly and effectively communicate with team members, other departments, and upper management
Quickly and effectively address challenges, from equipment malfunctions to staffing issues
Ensure a safe and compliant work environment
Schedule training for staff to ensure they are up-to-date on procedures and best practices
Preferred
Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus
Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus
Knowledge and experience in drug-device development, inhalation drug delivery is a plus
Experience with drug-device combination products is a plus
Company
Aerogen Pharma
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase