Analytical Chemist – Inhalation Drug Formulations & CMC

Aerogen Ltd.; Raleigh (NC); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive bonus plan

Above market life insurance

Opportunities for development and成长

Aerogen Connect

1% charitable giving

Job summary

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company, is seeking an Analytical Chemist to develop analytical methods for lipid‑peptide and lipid‑protein formulations and to support formulation development. The role involves hands-on lab work, regulatory documentation, and cross‑functional collaboration.

You will contribute to advancing our CMC program, establish analytical capabilities, and ensure quality and regulatory standards are met, while mentoring others in

Qualifications

• A degree in Analytical Chemistry, Chemistry, Biochemistry, or related field.
• 2‑5 years of analytical development or quality control experience.
• Experience in technical writing is required.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is a plus.
• Experience with lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilisation is a plus.
• Knowledge and experience in drug‑device development, inhalation drug delivery including aerosol characterization techniques is a plus.
• Excellent written and oral communication skills.

Responsibilities

• 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.
• 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.
• Assist with sample flow monitoring, test scheduling, and communicating with other departments to maintain project timelines.
• Assist with coordination, scheduling, and training on analytical procedures and operational processes.
• Support formulation development efforts by participating in formulation runs with guidance from formulation science staff.
• 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.
• Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals
• 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.
• Address and resolve complex analytical issues during development and manufacturing
• Stay updated on advancements in analytical techniques and industry trends

Skills

UHPLC

Mass spectrometry

Analytical method development

Data analysis

Technical writing

Laboratory teamwork

Education

Analytical Chemistry degree

Tools

CAD

Job description

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.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries What is the role?
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.

What are the key responsibilities?
• Analytical Chemistry: Develop and optimization analytical methods for characterizing 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 maximize 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 optimization, 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

What education and experience are required?
• A degree in Analytical Chemistry, Chemistry, Biochemistry, or related field
• 2-5 years of analytical development or quality control experience.
• Experience in technical writing is required.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is a plus.
• Experience with lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus.
• Knowledge and experience in drug-device development, inhalation drug delivery including aerosol characterization techniques is a plus.
• Excellent written and oral communication skills.

What key skills will make you great at the role?
• Understanding laboratory procedures, equipment, software, and data analysis.
• Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance.
• Technical Expertise: Proficiency in analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods.
• Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's 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: Compliance and safety: Ensure a safe and complaint work environment

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.
Equal Employment Opportunity
Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.

Salary Range for this position is estimated at $95,000-$120,000 and will depend on the candidate's skills, qualification and experience. The role is eligible for a performance-based incentive bonus and comprehensive benefit package including Medical, Dental, and Vision Coverage, 401k Retirement, Enhanced Global Life Insurance, Paid Time Off (15-20 days tenure related), Global EAP Program, Short-Term Disability and FMLA Benefits. The company reserves the right to adjust this pay range at any time.

Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications.