This position is responsible for conducting analytical and performance testing of formulations, contributing to pharmaceutical development and design, and/or support of GxP manufacturing activities. This position requires a significant understanding of the scientific foundations for analytical testing of pharmaceuticals.
- Plans and performs multi-part experiments and conducts activities in support of pharmaceutical formulation research and development; process development, engineering and/or cGxP operations
- Generates, analyzes, and tabulates data and results
- Processes and understands analytical results and draws scientifically sound conclusions based on the data
- Follows safety practices and procedures, using personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participate in identifying and resolving safety issues
- Troubleshoots instrumentation mechanical/operational problems independently
- Follows SOP’s, cGMP, and GLP regulations and procedures
- Maintains thorough and accurate research and laboratory documentation including experimental methods, observations, data, and results in support of SOP, cGMP, and GLP regulated activities
- Optimizes existing analytical methods independently to increase efficiency and/or quality of the data
- Develops new analytical methods/techniques with minimal supervision
- Writes analytical test reports and protocols with minimal supervision
- Interacts with internal project teams to describe analytical results and lead team through technical discussions
- May interact on external (client) project teams
- Continuous improvement
- May train technical staff; may oversee laboratory and/or technical activities, as appropriate
- Maintain current scientific knowledge through review of current scientific literature
Candidate Qualifications and Experience:
- BS/BA in a relevant scientific discipline plus 8 or more years relevant laboratory experience; or, a MS degree in a relevant scientific discipline plus 5 year relevant laboratory experience; or a Ph.D in a relevant scientific discipline, a demonstrated level of performance and capability as determined by management.
- Conduct assigned tasks under minimal supervision of senior scientific staff; perform assigned tasks by applying general procedures, methods, and scientific techniques; work on multiple activities in parallel.
- Capable of proposing alternative or revised methods and procedures for accomplishing experimental goals and procedures.
- Capable of implementing existing methods, assays, and processes to new situations or applications; able to troubleshoot and improve existing methods, assays, and processes.
- Thorough knowledge of relevant scientific principles and theories as well as the capability to use and apply standard scientific procedures and techniques.
- Knowledge of the scientific principles pertaining to and capable in the operation of standard laboratory, analytical, and/or processing and manufacturing equipment; examples include: analytical balances, HPLC, UV/Vis spectrophotometer, particle size analyzer, viscometry, emulsifiers, lyophilizers, etc.
- Recognize unanticipated or adverse outcomes or deviations; able to use technical expertise and experience to suggest possible causes of unanticipated outcomes or deviations and to propose corrective action or resolutions for problems of simple to moderate complexity.
- Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals that could potentially affect the health of the employee.
- Proficient in the use of word processing, spreadsheet, and presentation software programs.
- Effective written and verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to more senior technical staff.
- A thorough understanding and application of relevant scientific theories, principles, and methods.
- Capable of performing and applying standard scientific tests, procedures, and techniques.
- Experience with a variety of standard formulation, processing, analytical, and manufacturing equipment and instruments.
- Excellent written, verbal, and organizational skills.
- Ability to clearly present research findings to senior staff, at internal meetings, and to clients, when directed.
- Ability to train people and supervise laboratory or technical activities.
- Conduct activities with consideration to time schedules and overall project goals and objectives.