Research Associate II - Formulation

Simtra BioPharma Solutions•Bloomington, IN

51d•Onsite

About The Position

Simtra BioPharma 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 at Simtra. We 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. Why join Team Simtra? Because we: Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways. Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health. This role: The Research Associate II role is responsible for independently managing analytical method development, validation and transfer projects for internal and external clients or independently managing formulation development projects for internal or external clients. This role may also provide support for more senior scientists, as well as other departments within the Bloomington facility. This role reports to Associate Director of R&D and is 100% onsite at the Bloomington, Indiana facility.

Requirements

BS degree in Chemistry, Chemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Science or related scientific discipline required
2+ years 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, 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
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
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
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 and related regulations and guidance
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