Senior Scientist (Formulation Development)

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

Job summary

Join a forward-thinking company dedicated to pharmaceutical innovation. This role involves conducting complex development studies and ensuring stable product manufacturing. You'll engage in all stages of product development, from experimental design to regulatory submissions, while collaborating with a talented team. The position promises a dynamic work environment where creativity thrives, and your contributions will directly impact product quality and safety. With a comprehensive benefits package and opportunities for professional growth, this is an exciting chance to advance your career in the pharmaceutical industry.

Benefits

401(k) plan with company contributions

Paid vacation

Health benefits including medical, dental, and vision

Employee assistance program

Wellness program

Qualifications

• 5+ years of experience in pharmaceutical research and development.
• Experience in developing novel drug delivery systems is a plus.

Responsibilities

• Responsible for all stages of product development and stability monitoring.
• Plans and implements scientifically designed experimental programs.

Skills

Experiment Design

Statistical Analysis

Pharmaceutical Dosage Forms

Problem Solving

Education

Bachelor's Degree in Pharmaceutical Sciences

Master's Degree in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Tools

Lab Instruments

Statistical Software

Job description

Job Summary

Responsible for conducting development studies with increasing complexity in nature 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, but not limited to 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 to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing.
• Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
• Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems.
• Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
• Scales up the manufacturing process and transfers the technology accurately to the production plant.
• Sets product specifications based on stability results and according to FDA and ICH guidelines.
• Writes Chemistry, Manufacturing and Control (CMC) section for Regulatory submission.
• Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems.
• Establishes work priorities for assignments within his/her authority and keeps 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 in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3 years of related experience; or a PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences, Chemical/Biomedical Engineering with 0-3 years of related experience is required.
• Must possess skills of designing and executing experiments using different lab instruments and techniques.
• Must have knowledge of statistics and analysis/interpretation, and pharmaceutical dosage forms. Experience in developing novel drug delivery systems is a plus.
• Must be willing to perform drug product development for potent compounds, cytotoxic substances and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures (SOPs), training, and Personal Protective Equipment (PPE).
• Must be willing to travel domestically and internationally to production plants to support batch manufacturing, etc.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

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