Senior Scientist I, CMC Process Development

Responsibilities

• Oversee and perform experiments for late phase process development of API and regulated materials, including process improvement, impurity identification, and fate and purge studies
• Analyze and interpret experimental technical data
• Work with internal and external teams to manage the determination, supply, and specifications of regulated materials
• Maintain knowledge of process and project history as well as process development and regulatory issues
• Collaborate with Regulatory Affairs in the preparation of regulatory documents, including CTAs, IMPDs, NDAs, and MAAs
• Make oral presentations to scientists and management
• Guide, mentor and develop chemists across the team
• Support talent acquisition efforts
• Identify growth opportunities for team members to reach their full potential
• Work closely with other department members
• Recommend new ideas, synthetic routes, and technologies to support departmental goals

Requirements

• PhD in Chemistry or related field with 2 years of industry experience
• Master's Degree in Chemistry with at least 8 years work experience
• Bachelor's Degree in Chemistry with 10 years equivalent industry work experience
• Excellent verbal and written communication skills
• Excellent problem-solving skills
• Knowledge in synthetic chemistry and analytical technology, hands-on experience in syntheses and development of small molecule and large molecule drug candidates

Preferred

• Strong track record of scientific publication
• Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance
• Prior experience working with or within CDMOs

Benefits

Wisconsin pay range $115,000-$140,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.