Scientist I, CMC Process Development

Arrowhead Pharmaceuticals•Verona, WI

11h•$85,000 - $95,000•Onsite

About The Position

A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase process development and regulatory filings.

Requirements

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 Haves

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

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 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, 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