Lab Manager Analytical Development

About 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. Our goal is to create medically superior proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading shaping and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Additionally in partnership with The Bill & Melinda Gates Foundation we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

What is the role

The person in this role is responsible for establishing and maintain a state-of-the-art analytical development laboratory; including chromatography and physical characterization techniques that will support our efforts in developing commercially viable lipid-peptide and lipid-protein formulations. This role is crucial for advancing our CMC program for the Gates project as well as establishing analytical capabilities and in-house expertise in our expanding portfolio ensuring products meet rigorous quality and regulatory standards.

The person will be both hands on in the lab with deep technical knowledge as well as mentor and manage direct reports and will collaborate effectively with our external GMP testing and manufacturing partners.

What are the key 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.

What Education and Experience are 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 lipid formulations liposomes or related drug delivery technologies including homogenization and lyophilization is a plus.
• Experience in technical writing is required.
• 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.
• Excellent written and oral communication skills.

What key skills will make you great at the role

• Technical expertise: Proficiency in analytical techniques such as UHPLC mass spectrometry and CAD as they apply to lipid characterization methods. Experience with drug-device combination products is a plus. Deep understanding of laboratory procedures equipment software and data analysis.
• Data-driven decisions: Use lab data to make informed decisions about operations budget and performance.
• Budget and inventory management: Effectively manage the lab budget and resources. Maintain stock levels of reagents and equipment and oversee maintenance.
• Leadership management and communication skills: Motivate inspire and lead a team of analytical chemists. Clearly and effectively communicate with team members other departments and upper management.
• Problem-solving and strategic thinking: Quickly and effectively address challenges from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the labs objectives.
• Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment.
• Compliance and safety: Ensure a safe and complaint work environment.
• Training procedures quality: Schedule training for staff to ensure they are up-to-date on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements.

Why Aerogen Pharma

As a key member of Aerogen Group the global market leader in high performance aerosol drug delivery Aerogen Pharma is at a pivotal point in the companys life cycle. With plans to expand and centralize our US hubs over the next two years we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization inhaled devices and neonatology.

We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care where potential is recognized and professional development is encouraged.