Senior Manufacturing Engineer
BIND Therapeutics is looking to add a Senior Engineer to join our dynamic Manufacturing group. The candidate should 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.
Some 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 or nanotechnology is desired. Hands-on experience with analytical equipment (particularly particle sizing, HPLC, and microscopy), and lyophilization is also desired. Experience with chemotherapy drugs is preferred. The candidate will 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.
- Organize, evaluate, and present data in an effective and scientific manner.
- Help manage a pilot plant for scale up work, process development, and pre-clinical manufacturing.
- Specification, purchase and development of process equipment for cGMP manufacturing.
- Technology transfer of pre-clinical and clinical stage processes to cGMP contract manufacturers.
- BS or MS in chemical engineering, biomedical engineering, mechanical engineering, or related field.
- 10+ years of experience in biotech or pharmaceutical industry with experience in process development and/or manufacturing.
- Knowledge of cGMPs and sanitary process design
- Knowledge of chemical/process engineering principles
- Experience with process automation
- Experience in scaling up pharmaceutical processes
- Experience with specification / purchase of equipment skids
- Mechanically inclined
- ‘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
- Highly motivated
- Travel will be required (the frequency varies from approximately 10-20%)
- Knowledge of analytical instrumentation, particularly particle sizing and HPLC a plus
- Experience with chemotherapy drugs a plus
- Experience with polymeric drug delivery forms and experience with nanotechnology a plus
- Experience with lyophilization a plus
BIND Therapeutics is a clinical-stage nanomedicine platform company developing Accurins™, our novel targeted therapeutics. We are leveraging our Medicinal Nanoengineering® platform to develop a pipeline of Accurins, initially in oncology, as well as Accurins in collaboration with biopharmaceutical companies. Our lead drug candidate, BIND-014, is currently in Phase 2 clinical trials for non-small cell lung cancer and metastatic castrate resistant prostate cancer. Additionally, we have announced collaborations with Amgen, Inc., Pfizer Inc., AstraZeneca AB, and Roche to develop Accurins based on molecularly targeted APIs from their product pipelines. We are looking for highly motivated people who thrive on being challenged and working in a highly collaborative environment to join the team and play a key role in conducting rigorous, cutting-edge science.