MS&T Scientist II

Overview

The purpose of this position is to support the Company in the development and optimization of manufacturing processes, improving them and increasing the scale.  The ultimate goal is to develop processes that optimize the product yield and minimize the cost of production.  These products include injectables and nasal/sublingual sprays

Responsibilities

• Utilize and apply knowledge of basic scientific principles, theories and concepts to develop solutions to problems of moderate complexity.
• Design and conduct experiments at small and medium scales in co-ordination with R&D group.
• Collect and analyze data from development batches and provide process development reports and tech transfer reports.
• Provide input in developing robust process validation programs.
• Perform risk assessment and present ideas for modifying existing procedures and suggest alternative methods to improve results.
• Understand, keep current and apply current technology to include cGMP, sterile manufacturing techniques.
• Collaborate with Engineering, Operations, OpEx, and QA groups and prepare robust manufacturing records, technical reports and SOPs. Prepare, analyze and organize data for training, and meetings.
• Use statistical process control and other statistical tools for comparison and hypothesis testing. Apply engineering, pharmaceutical sciences or materials sciences fundamentals to model the product and process to solve complex technical problems.
• Provide technical expertise to resolve challenges that are associated with full-scale commercial production.
• Work in the aseptic compounding and filling processes and assist in maintaining the equipment used for production.
• Train and mentor new employees within the department. This includes but is not limited to processes, procedures in compliance with established protocols and regulatory guidelines.
• Work closely with internal and external departments to ensure the efficient progress of projects.
• Understand and comply with all Company safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as apllicable federal, state and local regulations.
• Represent the department in interactions with other departments as well as internal and external clients in various settings such as meetings, teleconferences, e-mails, printed reports, etc. 
• Strengthen inter-departmentmental relationships at the Individual Contributor level.

Qualifications

Bachelor’s Degree (BS) in Engineering or Natural Sciences required with a minimum of 3 years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience.