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Lead Chemical Process Engineer
2 months ago
Corden Pharma Boulder Inc is an esteemed contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, and pharmaceutical drug products. With a workforce exceeding 2,600 globally, we are dedicated to enhancing the quality of life through our comprehensive services that empower pharmaceutical and biotech firms in their medicine production endeavors.
Position Summary
This role entails providing robust technical and leadership guidance to process engineers engaged in both development and commercial projects. The individual will contribute significantly to process development, optimization, troubleshooting, and manufacturing support within the designated group or facility. Ensuring the precision, reliability, and compliance of documentation related to production and validation processes is paramount, alongside supporting investigations as necessary.
Key Responsibilities
The responsibilities of this position include:
- Leading and supervising process engineers, fostering a culture of technical excellence.
- Evaluating new processes for manufacturing, focusing on safety, cost, equipment, and chemistry.
- Conducting process development through modeling and lab-scale testing, with an emphasis on scale-up parameters.
- Identifying and implementing process improvements that enhance efficiency, reduce costs, and ensure quality.
- Providing technical documentation and support for manufacturing operations, including process flow diagrams and training materials.
- Engaging in process validation efforts by defining technical requirements and addressing deviations.
- Offering on-site support during the implementation of new processes and troubleshooting equipment issues.
- Generating estimates for commercial scale fits and contributing to capital project planning.
- Authoring technical reports to support regulatory submissions.
- Leading interdisciplinary teams on complex projects and providing updates to management on progress and challenges.
Leadership and Development
The successful candidate will mentor and develop less experienced engineers, setting performance goals and providing constructive feedback. Effective communication within the department and across the organization is essential.
Qualifications
A Bachelor’s degree in Chemical Engineering and a minimum of 10 years of experience in Process Engineering within a pharmaceutical or fine chemicals manufacturing context are required. The ideal candidate will possess strong analytical skills, a thorough understanding of regulatory compliance, and demonstrated leadership capabilities.
Core Competencies
Key areas of expertise include:
- In-depth knowledge of chemical engineering principles and process improvement methodologies.
- Experience with plant-scale operations and design considerations.
- Ability to apply statistical analysis to inform decision-making.
- Proficiency in Microsoft Office and relevant engineering software.
At Corden Pharma, we are committed to fostering an inclusive environment that values diversity and promotes professional growth.