• 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:

• Bachelors Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with five plus years of related experience or a Masters 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 zero to three years of related experience is required.
• Must possess skills of designing and executing experiments using different lab instruments and techniques.
• Must have knowledge of statistic 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 plant to support batch manufacturing, etc.

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