Senior Scientist (Formulation Development)

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 85,000 - 95,000; Full time

Job summary

An established industry player is seeking a dedicated professional to lead product development in a dynamic R&D environment. This role involves overseeing all stages of product development, from planning and executing experiments to ensuring compliance with FDA guidelines. The ideal candidate will have a strong background in pharmaceutical sciences and a passion for innovation in drug delivery systems. With a comprehensive benefits package and a commitment to employee well-being, this position offers the chance to make a significant impact in the field of pharmaceuticals while working alongside a talented team of experts.

Benefits

401(k) Plan with Company Contributions

Paid Vacation

Health Benefits

Employee Assistance Program

Wellness Programs

Qualifications

• 5+ years of experience in pharmaceutical research and development.
• Strong skills in experimental design and execution.

Responsibilities

• Oversee all stages of product development and stability monitoring.
• Plan and implement experimental programs in pharmaceutical R&D.

Skills

Experiment Design

Statistical Analysis

Pharmaceutical Dosage Forms

Drug Product Development

Education

Bachelor's Degree in Pharmaceutical Sciences

Master's Degree in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Tools

Laboratory Instruments

Job description

Job Summary

Responsible for conducting development studies with increasing complexity and solving problems to ensure a stable product can be manufactured in the production facility.

This position requires working onsite at our Melrose Park, IL R&D facility.

Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

Salary Range: $85,000-95,000

Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits including medical, prescription drug, dental, and vision coverage.

Responsibilities

1. Accept responsibility for all stages of product development, including on-site monitoring of stability lot manufacturing.
2. Plan, develop, and implement scientifically well-designed experimental programs, demonstrating creativity and capability in pharmaceutical research and development.
3. Identify problem areas and utilize scientific resources to recommend alternatives, priorities, and results to resolve problems.
4. Accurately and completely record experimental procedures, test results, and observations to meet corporate and GMP requirements.
5. Scale up the manufacturing process and transfer the technology accurately to the production plant.
6. Set product specifications based on stability results and according to FDA and ICH guidelines.
7. Write Chemistry, Manufacturing and Control (CMC) sections for regulatory submissions.
8. Responsible for product and process improvement, as well as ideas for new products, line extension, product stability improvement, and novel drug delivery systems.
9. Establish work priorities for assignments within authority and keep assignment completion on schedule.

Job Requirements

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience; or a Master's Degree with 3 years; or a PhD with 0-3 years of related experience.
• Skills in designing and executing experiments using various lab instruments and techniques.
• Knowledge of statistics, analysis/interpretation, and pharmaceutical dosage forms. Experience in developing novel drug delivery systems is a plus.
• Willingness to perform drug product development for potent compounds, cytotoxic substances, and/or controlled substances, following all safety procedures, including the use of engineering controls, SOPs, training, and PPE.
• Willingness to travel domestically and internationally to support batch manufacturing and other activities.

Additional Information

We offer an excellent salary and benefits package including medical, dental, and vision coverage, life insurance, disability, 401(k) with company contribution, and wellness programs.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.