Arrowhead Pharmaceuticals
Senior Scientist I, CMC Process Development
Verona, Wisconsin, United States · Senior
Sponsorship not specified$115k-$140kDetected 5 days ago
ComplianceProcess ImprovementRecruitingGMPFDA RegulatoryResearchAnimal StudiesCommunicationProblem SolvingPublic SpeakingRegulatory Affairs
About the role
- A Senior 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.
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
- 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.
- Guide, mentor and develop chemists across the team
- Support talent acquisition efforts
- 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
- or a Bachelor's Degree in Chemistry with 10 years equivalent industry work experience
- Knowledge in synthetic chemistry and analytical technology, hands-on experience in syntheses and development of small molecule and large molecule drug candidates
- Strong track record of scientific publication
- Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance
- Candidates must have current, valid authorization to work in the country where this role is located.
Skills
- Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
- Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Compensation
- Wisconsin pay range
Apply directly at Arrowhead Pharmaceuticals →Create a free account for alerts like thisView Arrowhead Pharmaceuticals immigration profile
This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.