Principal Analytical Chemist

CordenPharma 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. Company Overview 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. Summary 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. Essential Duties And Responsibilities 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. Leadership & Budget Responsibilities 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. Safety & Environmental Responsibilities Adhere to safety and environmental protocols in the workplace; use knowledge, training, and experience to perform duties safely. Qualifications 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. Education And/Or Experience Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience. Language Skills Read, analyze, and interpret scientific and analytical journals, financial reports, and legal documents. Respond to inquiries from customers, regulatory agencies, and business communities. Write speeches and articles; present information to top management, clients, public groups, and boards of directors. Mathematical Skills Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, permutations, statistical concepts including significant figures, frequency distribution, test reliability and validity, ANOVA, correlation, sampling theory, and factor analysis. Reasoning Ability Define problems, collect data, establish facts, and draw valid conclusions; interpret technical instructions in mathematical or diagram form, and handle abstract and concrete variables. Certificates, Licenses, Registrations Domestic and international travel required. Physical Demands Includes talking, hearing, standing, walking, sitting, use of hands, reaching, climbing, stooping, kneeling, crouching, crawling, tasting, smelling, and lifting up to 50 pounds. Vision requirements: close sight, distance sight, color vision, peripheral vision, depth perception, and focus adjustment. Work Environment Involves exposure to toxic and/or caustic chemicals, high‑potent compounds, moving mechanical parts, weather conditions, and electrical hazards. Noise level usually moderate. Core Competencies Scientific leadership in analytical chemistry for API synthesis Presentation and persuasion skills Training and facilitation skills Developed written and verbal communication skills Complete understanding of cGMP and GLP requirements Salary Actual pay will be based on your skills and experience. Benefits 401(k) matching – 100% contribution of first 6 % of salary, 100% vested after 2 years of service Accident Plan Critical Illness Insurance Dental Insurance Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance (PPO/HSA) Hospital Indemnity Plan ID Theft Protection Life Insurance Paid Parental Leave Tuition Reimbursement Wellness Program Vacation – Three Weeks 1st Year Vision Insurance Equal Opportunity Employer Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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