Head of Process Development BIND Biosciences
THIS JOB HAS EXPIRED This position will lead the process development of our Accurin? nanoparticle platform. The Head of Process Development will direct a team of engineers and scientists to lead the scale up, process understand, and initial manufacture of formulations for pre-clinical and clinical studies.
The ideal candidate will have knowledge and experiences related to the cGMP manufacturing in the pharmaceutical or biotechnology industries. He or she should possess specific knowledge of sanitary process design, process scale up, process automation, and chemical/process engineering principles. The candidate should have experience preparing batch records, lab reports, protocols, and other cGMP documentation and working in chemistry or process development labs or clinical manufacturing areas. The candidate should have good mechanical skills and the ability to work with laboratory and industrial process equipment.
Knowledge and experience with statistical design of experiments and analysis of results is desired. The candidate should be capable of critically analyzing, organizing, and communicating data. Specific experience with polymeric drug delivery forms, nanotechnology, analytical equipment (particularly particle sizing, HPLC, and microscopy), and lyophilization is preferred. Experience with chemotherapy drugs is also preferred.
This person must have the personality and social skills to work in a small company environment. This includes working closely with other departments and managing a functional group while representing process development on numerous project teams. Strong technical writing skills are a must, as this person will author and review drug product sections in the CMC sections of regulatory submissions. The candidate will also be needed to help outsource clinical manufacturing. Experience with CRO or CMOs is required. Travel will be required.
Effectively work with Pharmaceutical Science, Chemistry, Biology, and Development groups to integrate existing scientific capabilities and commercialize novel ideas.
Write and manage data acquisition and automation programs for manufacturing equipment skids.
Organize, evaluate, and present data in an effective and scientific manner.
Manage a lab and pilot plant for scale up work and process development.
Technology transfer of pre-clinical processes to manufacturing group.
BS or advanced degree in biomedical, chemical, or process engineering.
12 ? 15+ years experience in process development or manufacturing at a biotech or pharmaceutical company with experience in drug product development.
Experience leading a team
Knowledge of cGMPs and sanitary process design
Knowledge of chemical/process engineering principles
Knowledge of equipment and PLC-based automation.
Experience in scaling up pharmaceutical processes
'Hands on' lab worker
Good communication skills, particularly written
Experience preparing batch records, lab reports, SOPs, and other cGMP documentation
Good organizational skills
Experience with outsourcing and/or contract manufacturing
Affable personality; ability to perform well under stress
Experience with data acquisition and automation programs
Experience with polymeric drug delivery forms and experience with nanotechnology preferred
Knowledge of analytical instrumentation, particularly particle sizing and HPLC preferred
Experience with chemotherapy drugs preferred
Experience with lyophilization preferred
||101 Binney Street |
Cambridge, MA 02142
THIS JOB HAS EXPIRED