Sr. Chemical Process Engineer

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with over 2,600 employees worldwide. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives. Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules.

About the role

This role targets complex small molecules, peptides, and highly actives for active pharmaceutical ingredients. The Chemical Process Engineer performs research and development activities to design or improve processes or technologies, provides process engineering support for manufacturing, and leads project management for large-scale projects and technology transfers.

Responsibilities

• Apply knowledge of plant-scale unit operations, scale-up, and plant design considerations, especially for API production.
• Understand chemical reactivity, potential exotherms, cross-reactivity, side products, and waste streams.
• Evaluate new process fits into manufacturing, considering safety factors, standard cost, equipment, chemistry, and unit operations.
• Perform process development at the lab scale, focusing on key scale-up parameters from kilo-scale to full production.
• Support manufacturing by authoring operating procedures, SOPs, guidelines, PSI packages, developing process models, and assembling technology transfer packages.
• Lead or participate in technology transfers between manufacturing sites and implement innovative process scale-up technologies.
• Perform process validation on API processes.
• Apply QEH&S regulatory compliance principles (FDA, cGMPs, EPA, OSHA, PSM) in chemical and pharmaceutical manufacturing.
• Provide day-to-day support to manufacturing and process development, including troubleshooting, continuous improvement, change control, deviations, and investigations.
• Identify, evaluate, develop, and implement process improvements to reduce costs, improve yield, cycle times, product quality, and process robustness.
• Develop and implement detailed project plans, including technology transfers and process implementation in pilot and commercial-scale facilities.
• Lead teams in the development, transfer, troubleshooting, and improvement of chemical processes, including capital projects of medium to large size.

Requirements

• BS in Chemical Engineering and 7+ years of demonstrated success in process engineering within a Pharmaceutical or Fine Chemicals Manufacturing environment.
• Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
• Strong written and verbal communication skills, including the ability to present information to management, public groups, or boards of directors.
• Proficiency in applying advanced mathematical concepts (e.g., exponents, logarithms, quadratic equations, statistical analysis).
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Experience interpreting technical instructions in mathematical or diagram form.

Skills

• Statistical design of experiments and ability to draw sound conclusions from results.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Batch+, statistical analysis programs, and chemical engineering simulation software.
• Innovative problem-solving and continuous improvement mindset.
• Leadership in project management and technology transfers.
• Negotiation and influencing skills.
• Understanding of CordenPharma’s business goals and strategy.
• Effective cross-departmental communication and collaboration.

Physical Demands

• Frequent standing, sitting, and talking or hearing.
• Occasional walking, reaching, climbing, balancing, stooping, kneeling, crouching, or crawling.
• Occasional lifting and/or moving up to 25 pounds.
• Specific vision abilities: close vision, distance vision, depth perception, and ability to adjust focus.

Work Environment

• Occasional exposure to moving mechanical parts, fumes, airborne particles, low levels of toxic or caustic chemicals, outdoor weather, and vibration.
• Moderate noise level in the work environment.

Benefits

• 401(k) matching: 100% of the first 6% (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 Maternity/Paternity Leave.
• Tuition Reimbursement.
• Wellness Program.
• Vacation: Three weeks in the first year.