Senior Scientist, Formulation Development

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.

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 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.

Qualifications

Must be able to pass a pre-employment drug screen and background check.

Skills

Must possess skills of designing and executing experiments using different lab instruments and techniques.

Benefits

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.