Analytical Chemist

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 products.

At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life‑threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.
We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre‑clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

The analytical chemist will develop analytical techniques and conduct experiments to support the development of commercially viable lipid‑peptide and lipid‑protein formulations. In addition, the person will support formulation development efforts. 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 hands on in the lab with strong technical knowledge in analytical science and will be mentored to assist in formulation development efforts.

• Analytical Chemistry:
  Develop and optimisation analytical methods for characterising and controlling the quality attributes of lipid‑peptide and lipid‑protein formulations. Support formulation development and design of experiment studies.
• Laboratory Equipment:
  Maintain laboratory instrumentation and equipment through routine preventative maintenance, calibration, troubleshooting, minor repairs, vendor service activities, and equipment performance verification to maximise uptime and data integrity.
• Analytical Operations:
  Assist with sample flow monitoring, test scheduling, and communicating with other departments to maintain project timelines.
• Development and Training:
  Assist with coordination, scheduling, and training on analytical procedures and operational processes.
• Formulation Science:
  Support formulation development efforts by participating in formulation runs with guidance from formulation science staff.
• Regulatory Compliance:
  Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs). Determine key stakeholders and optimal process to drive patient demand generation and patient use in home setting.
• Cross‑functional
  
  Collaboration:
  
  Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals
• CDMO/CMO/CRO
  
  Collaboration:
  
  Manage method optimisation, validation, and transfer for procedures controlling the quality of lipids, proteins, and peptides. Ensure effective communication and coordination to meet project timelines and quality expectations. Ensure methods are robust and comply with industry standards.
• 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

• A degree in Analytical Chemistry, Chemistry, Biochemistry, or related field.
• 2‑5…