Analytical Chemist

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 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 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. 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 characterisation 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 centralise 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 commercialisation, inhaled devices, and neonatal care. We foster an inclusive culture that empowers you to contribute to the transformation of neonatal care, where potential is recognised, and professional development is encouraged. What is it like to work at Aerogen? Our purpose is to transform patient lives, and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non‑financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: Competitive bonus plan. Above market life insurance. Opportunities for development and professional growth. "Aerogen Connect" - our employee‑led programme that helps our global teams unite and have fun. We donate 1% of profits and time to charities and organisations. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace.