Lead Staff Scientist
Posted on Feb 14, 2020 by Thermo Fisher Scientific
The CM Development Lead Staff Scientist leads development teams for the successful launch of Oral Solid Dosage products from an innovative continuous manufacturing system. This role leads small cross cross-disciplinary teams in their efforts to analyze client products and execute process and formulation development projects. This role will work closely with Operations and Automation personnel to plan out projects and utilize shared resources and equipment.
What will you do?
Lead risk based formulation and process development, and technology transfer activities from batch to continuous manufacturing; including blending, granulation, compression, encapsulation, coating, and feeding studies.
Design and execute DoE studies to develop a quantitative understanding of the relationship between process parameters, material attributes, and product performance.
Perform in-depth data analysis on large data sets coming from the continuous manufacturing development processes to distill important process knowledge.
Interact closely with clients to plan and execute activities and advance projects forward.
Perform risk assessments for products targeted for continuous manufacturing.
Leadership of cross-functional teams in planning and carrying out development studies.
Perform root cause problem solving to determine strong corrective and preventative actions.
Write technical reports in support of Continuous Manufacturing development.
Provides technical recommendations to permit product manufacture within regulatory requirements (FDA, EMEA, OSHA, EPA, etc.).
Promotes a safe work environment for self, employees, customers, and other personnel to reduce personnel and environmental health and safety risks.
How will you get here?
Bachelors, Masters, PhD in Chemical Engineering or relevant physical science is strongly recommended.
Five to ten years of experience in pharmaceutical drug product development is required. Late stage development is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Must be creative, innovative, and possess a high degree of personal motivation.
Must be capable of managing multiple projects and leading cross functional teams to meet project milestones. Experience managing projects from the planning stages, through scheduling and execution, is required.
Excellent written and oral communication, as well as interpersonal and teamwork skills are essential. Must be able to communicate highly technical information and non-technical information to various levels of personnel throughout production and support areas, as well as with customers.
Ability to generate scientific/technical documents and presentations for scientific and production staff. Experience authoring development reports or regulatory filing documents is desired.
Experience using programming for analysis and visualizations of development data is required.
Must have a sound technical approach to problem solving with a high level of learning ability, plus excellent planning and organization skills.
Experience with continuous manufacturing in any industry is not required, but is preferred.
Must be able to quickly learn and exhibit a thorough knowledge of the unit operations within continuous manufacturing.
Due to sensitive proprietary information encountered, must be able to keep this information confidential.