Process Engineer II

Role Summary

The Process Engineer II will have responsibility for process development, process characterization, scale-up, and technology transfer activities, supporting new and existing pharmaceutical products.

Responsibilities

• Contribute to the design and execution of process development and process engineering experiments for fermentation /chromatography or other project related processes.
• Key member of a dynamic, scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.
• Key contributor to process development strategies to define manufacturing processes for clinical and commercial products.
• Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, using both experimental and process simulation/modeling approaches.
• Apply appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
• Manage external vendors and contractors as related to drug product manufacturing services and products.
• Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
• Prepare technical reports, publications, and oral presentations.

Qualifications

• Bachelor‚Äôs degree with 5+ years of pharmaceutical experience strongly preferred.
• Strong background in fermentation/chromatography purification of biopharmaceutical proteins both small scale and large scale.
• Strong background operating fermentation/chromatography equipment in the preparation of proteins at small and large scale.
• Extensive experience in pharmaceutical development as it relates to process development/optimization.
• Demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.
• Proven record of implementing novel and creative solutions to overcome process development obstacles.
• Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
• Ssolid understanding of GLPs and cGMPs during pharmaceutical development and commercial manufacturing.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Strong verbal and written communication skills are crucial.
• Experience managing third party vendors is a plus.
• High energy, innovative ‚Äúcan do‚Äù attitude is required.

Skills

• Process development and optimization
• Fermentation and chromatography operations
• Process characterization and modeling
• Regulatory compliance and quality systems
• Vendor management
• Technical reporting and presentation

Education

• Bachelor‚Äôs degree in a relevant field; advanced degree is a plus but not required based on qualifications.