Formulation Associate

MilliporeSigma; Indianapolis (IN); On-site; USD 65,000 - 118,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma seeks a scientist to lead bench-scale formulation and process development for sterile injectable products, including liposome and lipid-based systems. You will support scale-up and transfer to cGMP environments, collaborating with manufacturing and analytical teams.

The role requires a Bachelor’s in Pharmaceutical Sciences or Engineering and 1+ years of related experience; 3+ years preferred. Strong DOE, QbD, and problem-solving skills are essential. US work eligibility required.

Qualifications

• Bachelor's degree required in pharmaceutical sciences or engineering.
• 1+ years of engineering, formulation and process development experience.
• Ideally 3+ years in engineering, formulation and process development.

Responsibilities

• Execute development tasks using QbD approaches and DOE.
• Provide lab-scale support for manufacturing processes and tech transfer.
• Develop SOPs for new equipment/processes and update existing ones.
• Collaborate with analytical services for testing and stability.
• Present results with high data integrity and clear documentation.
• Communicate status with supervisor and team; address issues.
• Follow chemical hygiene and disposal procedures in lab.

Skills

Quality by Design

DOE principles

Lab-scale formulation

Process development

Education

Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, or engineering

Tools

LIMS

Minitab

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

In this role you will be responsible for key formulation and engineering support primarily dedicated to bench-scale formulations and process development activities associated with sterile injectable and lyophilized drug products, particularly liposomes and lipid-based formulations. The primary task would be to plan, support and execute experiments with the aim of optimizing processes for scale-up and/or transfer to the cGMP environment within the constraints of timelines and under minimal supervision by senior scientific staff. Additionally, the job responsibilities would include significant technical collaboration with the manufacturing and analytical technical services department as well as technical support for current processes and product investigations.

Responsibilities Include But Are Not Limited To

• Execute developmental and investigational tasks through Quality by Design (QbD)approaches utilizing DOE principles. Associated tasks include formulation development, process design and engineering, equipment specification and engineering, data collection and analysis, generation and testing of critical process parameters (CPPs) to match the critical product attributes (CPAs) of the final drug product.
• Provide technical support via lab-scale execution for the manufacturing processes, including process investigations, process changes, and technical transfer and scaleup of new product introductions. Adapt formulation solutions to complex products through guidance from senior scientific staff and collaborators
• Develop efficient, appropriate formulation procedures and Standard Operating Procedures (SOPs) for new equipment/processes as well as update of existing SOPs.
• Partner with the analytical technical services group to perform sample analyses in support of formulation development, in-process sampling and stability testing of final drug products/samples.
• Present quality written documentation, notebooks, methods, data reports and summaries. Report and treat data with a high level of integrity and ethics
• Discuss routinely with supervisor, project manager and peers the status of the assigned programs and potential problems. Communicate effectively on research results, issues, and plans.
• Conduct laboratory operations in a safe manner. Maintain compliance with the Chemical Hygiene Plan. Exhibit safety awareness and safe work practices.
• Follow responsible actions regarding chemical disposal in close collaboration with the EHS staff. Maintain compliance with appropriate SOP’s.
• The person may also be expected to interface with external clients and contractors in support of existing projects.

Physical Attributes

Lift up to 25 pounds.

Who You Are

Minimum Qualifications

• Bachelors Degree in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, or other Engineering discipline.
• 1+ years of experience in engineering, pharmaceutical formulation and process development.

Preferred Qualifications

• 3+ years of experience in engineering, pharmaceutical formulation and process development.
• Experience with LIMS or Minitab.
• Experience performing root cause analysis for investigations.
• Experience with statistical designs of experiments (DOE) methodology.

Pay Range for this position: $64,500 - $117,800 / year The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!