Cambrex Corporation (Cambrex) is a global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 35 years’ experience and a growing team of 2,000 experts, Cambrex is headquartered in East Rutherford, NJ, Cambrex and has twelve operational sites across North America and Europe.
The main purpose of the Crystallisation Project Scientist is to carry out crystallisation scale-up development projects to the highest technical standards, on the Active Pharmaceutical Ingredients (APIs) of Cambrex clients. These projects will be progressed from multi gram scale up to kilogram scale, where the process will be technology transferred to full scale manufacturing. Also, to facilitate closure of projects with minimal lead-time, whilst maintaining compliance to quality and safety systems, so that clients can progress development of their product / API.
- The Crystallisation Project Scientist is responsible for the organisation and performance of all crystallisation process development projects including characterisation of samples generated and provided by clients. The crystallisation scientist is expected to deal with a demanding workload whilst maintaining a high standard of work. As such, they must be well organised and capable of prioritising and responding to a number of deliverables from a range of clients.
- The Crystallisation Project Scientist is expected to be competent in the underlying science of process and scale-up crystallisation, having experience of crystallisation pathways such as cooling crystallisation, anti-solvent crystallisation etc. at gram and ideally kg scale.
- The Crystallisation Project Scientist is expected to be experienced in using controlled lab reactors (CLRs) in conjunction with heater/chiller units and overhead stirrers to manipulate crystallisation systems to optimise: purities, yields, particle size distributions or any other client specific objectives.
- A working knowledge of current PAT technology is required, such as FBRM, Raman and others. This is essential to understand and characterise the crystallisation system and MSZW (metastable zone width) for further optimisation and eventually technology transfer.
- The Crystallisation Project Scientist is expected to be competent in a wide variety of analyses using an extensive range of different techniques including specialist areas such as – DVS; XRPD; TG/DTA; DSC and more general areas including spectroscopic and wet chemistry methods.
- Masters / PhD in chemistry or chemical engineering.
- > 5 years of experience preferred.
- Experience in managing a team.
- Familiar with working within ISO9001 and/or cGMP quality standards.
- Experience in working independently and within a team in an R&D environment.
- Experience with working safely in a lab environment and adhering to local SHE policies.
- Able to participate in client meetings and discuss technical data clearly and succinctly.
- Possess excellent oral and written communication skills.
- Be well organized, and able to manage high workloads.
- Able to meet deadlines and plan one’s own work effectively.
- Possess good problem-solving skills.
- Be commercially aware of business development needs.