Research Associate II

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 routine analytical method development, validation and transfer projects for internal and external clients. This role also provides support for formulation scientists contributing to formulation development projects with minimal assistance and guidance. Additionally, this role may provide scientific support to other departments within the Bloomington facility. This role is onsite, and it reports to the Manager of Development Services.

The responsibilities:

• Without assistance, make sound technical recommendations regarding formulation and analytical projects
• Provide analysis of key experimental procedures and recommend appropriate designs, techniques, and processes for specific tasks, as applicable
• Use appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines
• Identify existing alternative methods and technologies for improving existing or new products/processes
• Maintain knowledge of relevant QSR (Quality System Regulation) and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
• Contribute to technical feasibility analysis of complex research and design concepts
• Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance and accurately assess results for validity and conformance to specifications
• Evaluate results relative to product requirements, definitions and/or program goals

Required qualifications:

• BS degree in a scientific discipline mandatory
• 2+ years laboratory experience
• Knowledge and understanding of GxP, GMP, and GLP regulations and guidance
• Experience in chromatography, spectroscopy and other analytical methods
• Ability to apply technical theories and principles to projects within area of expertise for non-routine tasks with some assistance
• Ability to objectively assess, organize, and clearly communicate complex information
• Ability to contribute on a project team and prioritize assignments to meet project schedules
• Demonstrates flexibility and ability to shift gears
• Microsoft Office Suite intermediate (or higher) proficiency

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
• Wear all PPE required by EHS (typically safety glasses, lab coat, gloves but may include a respirator)
• Requires handling of laboratory chemicals

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
• 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 12/31/24

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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