As a Scientist at the Capsugel Pharmaceutical R&D Center in Pearl River, NY, you will be responsible for the day-to-day execution of laboratory work, performing formulation development, process scale up, technology transfer for customers and internally developed products in the health & nutrition and pharmaceutical categories. Identifying and implementing new techniques and equipment or improving existing ones. Additional activities will include supporting analytical development and clinical and commercial manufacturing.
Responsibilities include, but are not limited to, the following:
- Formulation Development: Support formulation development and scale-up studies for oral solid dosage forms including powder and liquid filled capsules, lipid based drug delivery, multi-particulates, coating, granulations and other Capsugel technologies. Support pre-formulation and analytical activities for formulation development by performing solubility studies, physical and chemical stability studies and assays of active and degradation products. Design and perform in vitro test models to critically assess formulation and delivery effectiveness and stability. Support analytical efforts in method development and verification/validation for active compounds, impurities and degradation products for formulation development and manufacturing. Establish formulation development action plans in accordance with the deadlines agreed with the customer in the overall project plans. Perform a daily follow up of the project to ensure deadlines are met and communicated. Carry out analytical studies and check all technical results. Suggest improvements regarding products and technologies used for development work to sustain Capsugel quality and productivity objectives. Identify new technologies and procedures needed to carry out the projects.
- In vivo Studies: Design and prepare oral dosage form test prototypes for animal studies and coordinate all in vivo testing at external contract facilities. Plan and execute pK studies to investigate drug release profiles and bioavailability improvement. Review all data and technical reports and make recommendations on next steps and follow up studies.
- Process Development/Scale up: Design and implement manufacturing process, instrumentation and equipment from the laboratory scale through pilot plant and manufacturing scale up. Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality. Responsible for participating in new product scale up, equipment procurement, process optimization and technology transfer. Interface with all applicable departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology.
- Analytical Systems: Proficiency in chromatographic analysis, dissolution testing, particle size analysis and rheological measurements. Support the maintenance of analytical equipment, including parts and utilities required for operation. Support the maintenance of logbooks for analytical/process equipment.
- Communication: Ensure clear communication at all times in both written and verbal forms. Present (oral and written) to peers and supervisor; convey confidence to others when communicating analytical data and information and make project information available to the appropriate people. Independently determine and develop approaches to solutions. Ensure that projects are completed on schedule following established procedures and schedules. Should remain current with emerging trends in field and be able to apply that technology to projects.
- BS and/or MS degree in pharmaceutical sciences or chemistry.
- A minimum of 5 years’ experience in formulation development, process scale up or related field is essential to fulfilling this role.
- Lipid based drug delivery is high desirable.
- Strong knowledge of drug delivery with skills and experience in oral dosage formulation optimization and scale up are also highly desirable.
- Excellent communication skills are critical.