Development Scientist

Development Scientist Simtra BioPharma Solutions

• 3.

8 Bloomington, IN Job Details 1 day ago Benefits Paid parental leave AD&D insurance Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Paid time off Adoption assistance Parental leave Employee assistance program Vision insurance 401(k) matching Benefits from day one Life insurance Qualifications Microsoft Word Research design Biochemistry Laboratory safety Microsoft Excel Microsoft Outlook Chemical Engineering Developing new product formulations Scientific publications Pharmaceutical regulatory compliance Enterprise software Computer literacy Engineering process optimization 11+ years GMP Formulation chemistry Mid-level Minitab Bachelor's degree Continuous improvement Doctor of Philosophy Team management Biochemistry Master of Science Bachelor's degree in pharmaceutical sciences Mentoring Experimental design Developing new training programs Bachelor's degree in chemical engineering Quality standards in production Chemistry JMP Training & development Manufacturing Research and development project management Cross-functional collaboration Bachelor's degree in biochemistry Project leadership Research & development Leadership Technical Proficiency Doctoral degree in biochemistry Doctoral degree in pharmaceutical sciences Bachelor's degree in chemistry Training delivery Statistical analysis tools Full Job Description 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.

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:

Bachelor's 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, 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 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. Data Privacy To learn more about Simtra's approach to data privacy, please review the

Simtra Recruitment Platform Global Privacy Policy:

https://simtra.com/privacy-policy/