Research Associate II - Analytical

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. They are also responsible for supporting formulation development projects for internal or external clients. This role reports to the Research Scientist II and is 100% onsite at the Bloomington, Indiana facility.

The 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
• 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

Required qualifications:

• 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.)

Physical / safety requirements:

• 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

In return, you'll be eligible for [1]:

• Day One Benefits
  
  
  
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    
    
    
    • Spouse Life Insurance
    • Child Life Insurance
    
    
    
    
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    
    
    
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
    
    
    
    
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  
  
  
  
• Additional Benefits
  
  
  
  • Voluntary Insurance Benefits
    
    
    
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
    
    
    
    
  • Onsite Campus Amenities
    
    
    
    • Workout Facility
    • Cafeteria
    • Credit Union
    
    
    
    
  
  
  
  

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

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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