Senior Scientist, Engineering II
Conceive and execute novel scientific research or development that achieves projects and area goals. Generate new scientific proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research or development programs.
Key Responsibilities Include:
Key Responsibilities Include:
- Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
- Publish research in peer-reviewed journals and present work at scientific conferences.
- Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program.
- Seize opportunities to pursue project relevant leads that are in line with the group's strategy.
- Maintain a high level of productivity in the lab.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
- May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
- Has experience with technology transfer of small molecule chemical process from lab and pilot scale to production manufacturing facility.
- Has developed a strong understanding of commercial manufacturing facility equipment such as reactors, centrifuges, filters dryers and auxiliary piping and utilities.
- Conceptualizes and implements novel approaches using combinations of engineering scientific principles.
- Utilizes knowledge of engineering, literature, and experience to guide decision for complex situations
- Must have an in-depth understanding of the cause/effect relationship to use for improvements to multiple processes and products.
- Designs and coordinates experiments to test hypothesis related to project outcomes; extracts the full relevance of scientific observations.
- Applies extensive, advanced scientific knowledge to multidisciplinary projects.
- Implements new technical alternatives for research from literature review, industry knowledge, and extensive development experience.
- Anticipates, recognizes, and resolves problems. Functions as an expert in technical/functional areas. Shows understanding of the issues relevant to the broad organization and business. Keeps that knowledge up to date and uses it cross functionally.
- Champions new technologies demonstrate applicability departments/business units. Provides peer review on process validation and product design strategies.
- Presents results of projects both internally and externally.
- Reviews and critiques presentations for others. Consistently and effectively presents complex technical data to large and diverse groups.
- Leads cross-functional technology transfer teams including team members from development and manufacturing.
- Interacts with cross functional teams and shares information. Leads team activities. Has demonstrated technical leadership in a multi-disciplinary environment. Creativity and ingenuity have been demonstrated through the development of novel disciplinary approaches to projects and strategic issues
- Previous experience with technology transfer and/or scaling up the process from lab / pilot scale to production scale in a commercial manufacturing facility.
- Develops and implements processes and programs to optimize or achieve the plant efficiency program, product quality control, cost control, customer specification or product design changes.
- Leads troubleshooting of product failures and recommends remediation direction.
- Coordinates technical effort or update documents required to appropriate quality file or regulatory agent.
- Provides leadership in coordinating the activities and strategies
- Experience with isolations of API is desired crystallization, polymorph control, drying, PSD control)
- Bachelor's Degree or equivalent education and typically 12 years of experience, Master's Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
- Possess thorough theoretical and practical understanding of own scientific discipline.
- Effective writer and communicator of research or other regulatory materials