Scientist I, CMC Process Development at Arrowhead Pharmaceuticals

Verona, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Aug, 26

Salary

95000.0

Posted On

21 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Small Molecule Chemistry, Conjugation Chemistry, Process Development, Impurity Identification, Fate And Purge Studies, Regulatory Filings, Synthetic Chemistry, Analytical Technology, cGMP Manufacturing, CDMO Management, Technical Data Analysis, Mentoring

Industry

Biotechnology Research

Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 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. 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 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 Preferred Strong track record of scientific publication Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance Prior experience working with or within CDMOs Wisconsin pay range $85,000—$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Responsibilities

Oversee and perform experiments for late phase process development of API and regulated materials, focusing on process improvement and impurity identification. Collaborate with internal teams and Regulatory Affairs to prepare essential regulatory documents and manage material specifications.