Simtra BioPharma Solutions is looking for a Research Associate I to independently manage analytical method development, validation, and transfer projects, as well as formulation development projects for internal and external clients. This role will support the R&D department in bringing sterile injectable products to market by ensuring quality and continuous improvement.
Requirements
- Experience in chromatography, spectroscopy and other analytical methods
- Good scientific technique in a corporate laboratory setting
- Microsoft Office Suite (Word, Excel, and Outlook) advanced to expert proficiency
- Experience with following software and/or programs: Minitab, JMP, or Python
- Knowledge and/or ability to use Enterprise software (i.e., JDE, BPLM, Pilgrim, Trackwise, etc.)
- Act as an Analytical Instrument Subject Matter Expert and supports instrument validations and/or periodic review validations
- Contribute to technical feasibility analysis of complex research and analytical method concepts
Responsibilities
- Assist with the planning and execution of a series of design and/or technical projects (small and large molecules) that may or may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines from early pre-formulation/formulation development to technical transfer of established formulations and processes in manufacturing operations
- Develop customer project proposals and activity schedules
- Lead the evaluation, selection, and adaptation of new technologies and techniques to accomplish business objectives, such as quality and cycle-time
- Provide responsive customer service to external customers by acting as project manager of R&D limited customer projects, scheduling meetings, providing agendas and issuing meeting minutes
- Support department Enviornmental Monitoring System (EMV) and Quality initiatives
- Learn how to devise new approaches to complex formulation and process development problems through adaptations and modifications of standard technical principles and incorporate new methods and technologies for improving existing or new products/processes
- Maintain current knowledge of relevant quality and regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
Other
- BS degree in Chemistry, Biochemistry, Pharmaceutical Science or other closely related scientific discipline required, with 0-2 years of laboratory experience
- Strong written and oral communication skills with the ability to interact with external and internal stakeholders
- Duties may require overtime work, including nights and weekends
- Position requires sitting for long hours, but may involve walking or standing for periods of time
- Practice safe laboratory practices
