Sr. MSAT Development Engineer

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. 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.

About the role

The Sr. MSAT Development Engineer provides technical leadership and documentation support for commercial manufacturing processes. Strategically develops, troubleshoots, and implements improvements to commercial or near-commercial processes, including engineering, chemistry, and technology that significantly improve the environment, safety, compliance, robustness, efficiency, schedule adherence, and cost aspects of manufacturing. Works within a team-oriented environment with professionals from a variety of disciplines. Conducts research, experimentation, and documentation for process troubleshooting, new technology implementation, and process improvements.

Responsibilities

• Acts as a technical lead/SME providing technical expertise and support during lab or plant operations, including the development, transfer, or implementation of technology at a lab or plant scale.
• Provides day-to-day support to manufacturing and process development, at times requiring attention outside of normal work hours. Support includes troubleshooting and continuous improvement of processes, as well as participation in change control, deviations, and investigations to ensure schedule adherence.
• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CordenPharma Colorado (CPC) customers related to assigned duties.
• Develops and supports scalable process improvements and provides technical expertise and support during lab and plant operations. Ensures process improvements are capable of meeting defined cost, yield, throughput, quality, and safety expectations on assigned processes.
• Responsible for supplying management with specific project data to facilitate the budgeting process for the transfer or implementation of technology. Works to identify trends and other improvement opportunities.
• Conducts root cause analysis for process-related failures and identifies corrective and preventative actions from their own investigation.
• Implements, troubleshoots, and helps to maintain process analytical technology (PAT) in operations. Provides technical leadership in identifying and deploying PAT strategies that enhance process understanding, strengthen control strategies, and improve manufacturing performance.
• Responsible for the equipment sizing, scale-up engineering, and execution of multi-step syntheses from laboratory to plant scale campaigns.
• Demonstrates a positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons.
• Adheres to safety and environmental responsibilities, performing job duties in a safe manner utilizing all knowledge, training, ability, and experience.
• Follows Current Good Manufacturing Practices (cGMP) to ensure products are consistently produced to accurate quality standards, adhering to clearly defined procedures in compliance with cGMP principles.

Requirements

• BS in Chemical Engineering and/or Chemistry with Master’s or Ph.D. degree preferred and 5 years of demonstrated success in Process Engineering or Process Chemistry in a Pharmaceutical or Fine Chemicals Manufacturing environment; or equivalent combination of education and demonstrated success, preferably specializing in Pharmaceutical Manufacturing Processes.
• Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
• Ability to work with concepts such as limits, and quadratic and exponential equations.
• Ability to select and perform engineering correlation calculations in support of scale-up (and scale-down) of processes. Familiarity with statistical design of experiments and process control.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
• Ability to deal with a variety of abstract and concrete variables.

Skills

• Demonstrates a positive attitude, strong technical curiosity, and commitment to continuous improvement.
• Applies chemical engineering fundamentals and a strong understanding of engineering, chemistry, quality, safety, and manufacturing principles.
• Utilizes statistical tools, including Design of Experiments (DOE), to support process development, optimization, troubleshooting, and data-driven decision making.
• Independently designs and executes laboratory studies, generating high-quality data to support process development and manufacturing investigations.
• Demonstrates expertise in process development, scale-up, optimization, technology transfer, and troubleshooting of chemical and pharmaceutical manufacturing processes.
• Experienced in the application of Process Analytical Technology (PAT), including UV/Vis, Raman, ReactIR, FBRM, PVM, EasyViewer, turbidity, and other advanced process monitoring tools.
• Working knowledge of crystallization, precipitation, thermal hazard assessment, calorimetry, and solid-state characterization techniques (XRPD, DSC/TGA, microscopy, etc.).
• Hands-on experience with chemical reactions, distillation, filtration, drying, purification, and other unit operations relevant to API and peptide manufacturing.
• Broad understanding of chemical reactivity, process hazards, exothermic reactions, impurity formation, waste streams, and process safety considerations.
• Experience supporting the development and manufacturing of peptides, small molecules, and highly potent compounds, with emphasis on peptide processes.
• Maintains accurate laboratory documentation and prepares technical reports, development reports, and manufacturing campaign summaries.
• Strong understanding of technical and operational requirements needed to establish robust, scalable, and commercially viable manufacturing processes.
• Identifies, leads, and implements process improvement initiatives that enhance safety, quality, reliability, efficiency, and cost performance.
• Proactively identifies and resolves technical challenges using scientific and engineering principles.
• Effectively communicates technical information to cross-functional teams, management, and stakeholders through clear written and verbal communication.
• Provides technical leadership and expertise in process development, technology transfer, process monitoring, troubleshooting, and continuous improvement activities.
• Influences decisions and drives alignment across multidisciplinary teams through collaboration, negotiation, and technical leadership.
• Contributes to departmental objectives and site strategy through goal setting, project leadership, and technical decision-making.
• Understands business objectives and aligns technical priorities with operational and organizational goals.
• Maintains a strong working knowledge of applicable regulatory and compliance requirements, including FDA, cGMP, OSHA, EPA, PSM, and QSHE standards.
• Proficient in Microsoft Office applications, statistical analysis software, LIMS (e.g., LabWare).

Physical Demands

• Regularly required to talk or hear.
• Frequently required to stand, walk, and sit.
• Occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and smell.
• Must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

• Frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals.
• Occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock.
• Noise level in the work environment is usually moderate.