Sr. MSAT Development Engineer

Corden Pharma Colorado• Boulder, CO, US, CO

4d•$105,000 - $126,000•Onsite

About The Position

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 such purposes as process troubleshooting, new technology implementation, and process improvements. Process improvements can include raw material studies, robustness improvement, throughput improvement, waste stream reduction, process analytical technology (PAT) implementation, etc. Responsible for the equipment sizing, scale-up engineering, and execution of multi-step syntheses from laboratory to plant scale campaigns. Emphasis is on the creative application of a full range of practical and theoretical concepts toward the design and implementation of cost-effective processes and improvements for the manufacture of Corden pharmaceuticals.

Requirements

A 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.
The 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.
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.
Demonstrates a 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., LabVantage), SAP, and other business and laboratory systems.

Nice To Haves

Master’s or Ph.D. degree preferred
Specializing in Pharmaceutical Manufacturing Processes

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 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 identify correct 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.

Benefits

401(k) matching - Corden Pharma will contribute 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 Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance