Simtra BioPharma Solutions needs to manage analytical method development, validation, and transfer projects, as well as formulation development projects, to support internal and external clients in bringing sterile injectable products to market.
Requirements
- Expertise in fundamentals of freeze-drying, including characterization of formulations intended to be freeze-dried, heat and mass transfer operations in freeze-drying, process analytical technology, and characterization of lyophilized solids or experience in chromatography, spectroscopy and other analytical methods
- Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
- Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, etc.)
Responsibilities
- Independently plan and execute a series of design and/or technical tasks that have multiple variables and require advanced techniques within negotiated deadlines (scope of these projects includes both small and large molecules and may vary from early pre-formulation and formulation development work to support of technical transfer of established formulations and processes to manufacturing operations)
- Lead the evaluation, selection and adaptation of new technologies and techniques, which accomplish business objectives such as quality and cycle-time
- Devise new approaches to complex formulation and process development problems through adaptations and modifications of standard technical principles
- Incorporate new methods and technologies for improving existing or new products/processes
- Supports instrument validations and/or periodic review validations
- Contribute to technical feasibility analysis of complex research and analytical method concepts
- Evaluate results relative to product requirements, definitions and/or program goal
Other
- 100% onsite at the Bloomington, Indiana facility
- May provide training and supervision to junior members within the department or plant and routinely provide advice and assistance to team members regarding unique problems
- Provide responsive customer service to external customers and provide internal project managers with requested information and updates
- Support department EMS (Enterprise Management System) and Quality Assurance initiatives
- 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
