We have an exciting Crystallization Engineer opportunity at our facility in Devens, MA. The Crystallization Engineer will be the expert in the area of crystallization and solid-state chemistry and will provide hands-on laboratory leadership in implementing complex crystallization design, optimization, particle engineering, solid-liquid separation and drying.

The successful candidate will be responsible for developing state of the art crystallization processes for the isolation of both active pharmaceutical ingredients and intermediates with the objective of controlling critical quality attributes and bulk properties. He/she will be responsible for the introduction and development of new particle engineering technologies to enable the manufacture of materials with controlled particle size, surface area and powder flow properties, in addition to developing crystallization process characterization & validation strategies.

He/she will coordinate the technical transfer of processes from the laboratory to manufacturing as necessary, including  contributions to technology transfer documentation, relevant sections of regulatory documents, validation protocols and development reports.

Key Responsibilities

• Develop, optimize and scale up robust and reproducible crystallization processes, including subsequent solid-liquid separation, and drying operations
• Develop industrially relevant and reliable procedures to control the purity, polymorphic form and the size of particles by means of suitable technologies like crystal engineering and milling
• Designs appropriate plans to meet project goals within the required timeline and budget
• Champions strategies for process development & characterization based on fundamental understanding of crystallization as well as application of statistical and/or first principle models
• Responsible for crystallization scale-up and technical transfer from lab to manufacturing
• Identifies industry trends and defines/champions the implementation of novel technologies
• Serve as departmental SME, mentor and train others on best-practices for solid state characterization, crystallization design & implementation
• Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer-reviewed manuscripts
• Influences and supports initiatives related to driving scientific and technical improvement within function and cross-functionally
• Exhibits a high level of safety awareness and conducts lab operations in a safe manner and holds others accountable for safe behaviour in the work environment
• Review scientific literature and apply theoretical knowledge to create solutions
• Work collaboratively with interdisciplinary teams
• Based on level of experience, the successful candidate will lead a matrixed team and/or direct reports

Are you the ideal candidate?

• PhD in Chemical Engineering or Chemistry with a focus on controlled crystallization of organic compounds
• 5+ years of relevant pharmaceutical industry experience
• Demonstrated expertise in crystallization process development and scale-up with an emphasis on control of polymorph, purity, bulk properties and particle size
• Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control
• Experience in developing continuous crystallization processes desirable
• Expertise in the use of process analytical technologies (e.g. FBRM, FTIR)
• Sound knowledge of current Good Manufacturing Practices (cGMP)
• Previous experience with managing technology transfers
• Experience in working in a multi-disciplinary team environment
• Experience leading and mentoring technical staff & proven track record of scientific excellence through presentations at conferences and publication of peer reviewed manuscripts.