Principal Analytical Chemist

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well‑being.

Performs and leads analytical research and development activities for the purpose of designing or improving a manufacturing process or technology, and producing clinical trial batches.

• Lead large and/or multiple teams to accomplish technology transfers and/or development projects.
• Apply analytical and organic chemistry skills to improve processes.
• Participate in the budget process of research projects and/or technology transfers.
• Initiate and execute the development of new and innovative analytical chemistry methodologies, providing written procedures and reports to support manufacturing and regulatory needs; lead analytical technology transfer activities.
• Develop a comprehensive understanding of internal, corporate, and ICH stability guidelines to support the Corden Stability Program.
• Apply analytical techniques at a process scale (e.g., process chromatography).
• Manage the analytical sections of process procedures.
• Develop key technologies and transfer strategies that function well in a manufacturing environment.
• Plan and formulate aspects of analytical R&D proposals, including objectives, applications, costs, equipment, and human resource requirements.
• Identify analysis points, develop methods, and devise/complete method validation studies.
• Communicate progress to management and clients, maintaining documentation such as analysis data, procedures, and progress reports in accordance with GLP and company policies.
• Submit patents, present at scientific conferences, and publish in scientific journals.
• Investigate new analytical technologies and equipment for practical utilization in manufacturing processes.
• Develop expertise in advanced analytical techniques.
• Analyze batches of drug substance intermediates and raw materials for the clinical registration program.
• Propose analytical specifications for raw material, intermediate, in‑process testing, and drug substance control.
• Participate in manufacturing site activities, including troubleshooting and analytical problem solving.
• Develop a thorough understanding of QEH&S principles and regulatory affairs; impact analytical process development in at least two areas.
• Properly manage the generation and accumulation of hazardous and non‑hazardous waste.

Demonstrate a positive attitude, support a healthy work environment, and lead teams in the development, troubleshooting, transfer, and improvement of chemical processes. Carry out leadership responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, directing work, appraising performance, rewarding, disciplining employees, and addressing complaints.

Adhere to safety and environmental protocols in the workplace; use knowledge, training, and experience to perform duties safely.

Requirements are representative of the knowledge, skill, and/or ability necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience.

Read, analyze, and interpret scientific and analytical journals, financial reports, and legal documents. Respond to inquiries from…