Research Associate II - Analytical

Overview

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

• 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
• May provide training to other employees within the department or plant
• Routinely provide advice and assistance to team members regarding unique problems
• Provide responsive customer service to external customers and internal project managers
• Support department Enterprise Management System (EMS) and Quality Assurance initiatives
• 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
• Develop an in-depth knowledge and understanding of Good Manufacturing Practices (GMP) and related regulations and guidance
• 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

• 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)
• 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
• Strong written and oral communication skills with the ability to interact with external and internal stakeholders
• 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.)

• 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

[1] Current benefit offerings are in effect through 12/31/25

• Medical & Dental Coverage
• Flexible Spending…