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Associate Director of Analytical Development (Biologics/Proteins/Peptides)

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 Analytical Development of all methods for both the Aerofact and Gates programs. This role is crucial for advancing our lipids, proteins, and peptides portfolio, ensuring products meet rigorous quality and regulatory standards. Effective collaboration with CMOs and CDMOs is a must-have to this role.

What are the key responsibilities?
• Leadership & Strategy: Oversee analytical development for biologics, proteins, and peptides, managing projects with CDMOs. Develop and execute strategies aligned with Aerogen Pharma’s mission and regulatory standards.
• Analytical Methods: Design, validate, and optimize methods for characterizing and controlling the quality of lipids, proteins, and peptides. Experience with protein and lipid analytical characterization including LCMS is essential. Ensure methods are robust and comply with industry standards.
• CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing / analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations.
• Regulatory Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements.
• Cross-Functional Collaboration: Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate analytical development with overall project goals.
• Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing. Implement corrective and preventive actions as needed.
• Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends. Drive continuous improvement within the team and processes.

What education and experience are required?
• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical chemistry, or related field.
• At least 5-7 years in analytical development / validation for lipids, proteins, or peptides, with a minimum of 2-3 years in a leadership role.
• Extensive experience working with CDMOs required. Late-stage experience required.

What key skills will make you great at the role?
• Technical Expertise: Proficiency in analytical techniques such as HPLC, mass spectrometry, and other lipid/protein characterization methods. Experience with proteins / peptides  and / or lipid based products and drug-device combination products is a plus.
• Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for BLA. Late-stage experience is essential.
• Leadership Skills: Proven ability to lead and develop high-performing teams with excellent interpersonal and communication skills.
• Problem-Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges.

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 company's 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.


Location
Pharma USA

Department
Pharmaceutical

Job Title
Associate Director of Analytical Development (Biologics/Proteins/Peptides)

Salary

Experience

City
San Mateo, California

Country
USA