Simtra BioPharma Solutions needs to partner with pharmaceutical and biotech companies to bring their sterile injectable products to market. This role is responsible for independently managing analytical method development, validation and transfer projects, and supporting formulation development projects to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Requirements
- Expertise in fundamentals of freeze-drying, including characterization of formulations intended to be freeze-dried and characterization of lyophilized solids
- Experience in chromatography, spectroscopy and other analytical methods (i.e. HPLC, CE, ELISA, UV, FTIR, etc.)
- Good scientific technique in a corporate laboratory setting
- Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
- Experience with following software and/or programs: Minitab, JMP, or Python
- Knowledge and/or ability to use Enterprise software (i.e., JDE, Veeva, Trackwise, etc.)
- Develop an in-depth knowledge and understanding of Good Manufacturing Practices (GMP) and related regulations and guidance
Responsibilities
- Independently plan and execute 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
- Lead the evaluation, selection, and adaptation of new technologies and techniques to 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 and incorporate new methods and technologies for improving existing or new products/processes
- Act as an Analytical Instrument Subject Matter Expert and support 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 goals
- 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 related scientific discipline required
- 2+ years of laboratory experience (MS or PhD in Chemistry, Biochemistry, Pharmaceutical Science, or related scientific discipline in lieu of laboratory experience)
- Strong written and oral communication skills with the ability to interact with external and internal stakeholders
- May provide training to other employees within the department or plant
- Routinely provide advice and assistance to team members regarding unique problems
