Arrowhead Pharmaceuticals
biopharmaceutical
ScientistI,CMCProcessDevelopment
“Scientist I, CMC Process Development at Arrowhead Pharmaceuticals. Skills: late phase process development, small molecule and conjugation chemistry, API and regulated materials development, synthetic chemistry, analytical technology. Oversee and perform experiments for late phase process development of API and regulated materials. process improvement”
What You'll Achieve.
generate knowledge and documents to support late phase process development and regulatory filings
Industry & Context.
Excellent problem-solving skills
current, valid authorization to work in the country where this role is located
What They're Looking For.
Must Have
Master's Degree in Chemistry with at least 5 years work experience or Bachelor's Degree in Chemistry with at least 8 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
Nice to Have
Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance, Prior experience working with or within CDMOs, track record of scientific publication
What You'll Do.
Oversee and perform experiments for late phase process development of API and regulated materials
impurity identification
fate and purge studies
Analyze and interpret experimental technical data
Manage the determination
and specifications of materials for Arrowhead’s late phase drug substance programs
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
mentor and develop chemists across the team
Support talent acquisition efforts
Identify growth opportunities for team members to reach their full potential
and technologies to support departmental goals
How You'll Work.
Team & Collaboration
Work with internal and external teams to manage the determination, supply, and specifications of materials; Collaborate with Regulatory Affairs in the preparation of regulatory documents; Work closely with other department members
Communication Scope
Excellent verbal and written communication skills; Make oral presentations to scientists and management
Process & Methodology
Manage the determination, supply, and specifications of materials for Arrowhead’s late phase drug substance programs, Maintain knowledge of process and project history
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