Development Scientist

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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.

The role:

The Development Scientist role is responsible for independently managing development projects and investigating improvements of technology that advance formulation development process development and manufacturing at Simtra. This role is also responsible for training scientists in formulation and process development for injectable products. The scientist reports directly to the Global Senior Scientist.

The responsibilities:

• Independently design and manage research studies that demonstrate the scientific capabilities at Simtra solve challenging process development problems for potential clients and that can be published in peer-reviewed journals and presented at scientific meetings.
• Collaborate with scientists in Bloomington and Halle to introduce potential new clients to Simtra learn about their molecule / project and propose possible directions for developing the product.
• Collaborate with the development scientists at both sites to overcome possible challenges in the development of a product.
• Investigate possible solutions to challenges that may be encountered during product development.
• Develop and utilize a digital twin during conjugation and purification of antibody drug conjugates and possibly other areas of development and manufacturing.
• Develop implement and optimize techniques and procedures in the field of formulation and lyophilization development or analytical development and validation. Develop a deeply differentiated technical skill set to contribute to department capabilities for product development.
• Sought out by other teams and individuals to offer technical advice; may act as coach mentor supervisor and technical advisor to junior members within the discipline.
• Implement new or improved techniques and procedures around specific tasks. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
• Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories methods and technologies from around the world to develop new innovative products/processes.
• Examine the use of predictive modeling and data analysis for formulation and process development to improve platforms for client projects.
• Utilize operational excellence and statistical tools to improve experimental design process efficiency or quality/compliance.
• In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation review adoption and interpretation of such regulations.
• Maintain current knowledge of relevant quality and other regulatory requirements related to research and development (product development design and safety) to ensure compliance in all research data collection and reporting activities.
• Investigate routes of collaborating with start-ups or other companies to obtain funding for research and development initiatives.
• Interact and collaborate with Sales Marketing and Program Management groups to professionally introduce potential new clients to Simtra Development and Pre-Commercial Services as well as other teams and capabilities.
• Develop and conduct scientific training programs in formulation and process development for BDEs PM and clients in collaboration with business development.

Required Qualifications:

• Bachelors degree in Chemistry Biochemistry Pharmaceutical Science or a scientific discipline with at least 15 years of relevant experience or MS with at least 10 years or a scientist with a PhD in Pharmaceutical science Chemical Engineering or a scientific discipline.
• Lab experience includes research in GMP environment leadership of technical teams and project management experience is desirable.
• Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: TCU Trackwise etc.)
• Strong statistical skills and ability to use standard statistical software (examples include MiniTab JMP) preferred.

Physical / Safety Requirements:

• Wear all PPE required by EHS (typically safety glasses lab coat gloves but may include a respirator).
• Duties may require overtime work including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• This position requires handling of laboratory chemicals
• Must be able to qualify for 20/25 corrected vision.

In return youll be eligible for1:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life 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
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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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