Scientist II, CMC Process Development
About The Position
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Arrowhead is seeking a motivated process development scientist to join our Chemistry Manufacturing and Controls group focusing on formulation and drug product. The successful candidate will be tasked with managing external drug product manufacturing and developing drug product formulations.
Requirements
- M.S. with at least 5+ years or B.S. with at least 7+ years of relevant industrial academic experience
- Experience with formulation development or drug product manufacturing.
- Excellent analytical, critical thinking, and communication skills
- Proactive, solutions-oriented mindset to anticipate challenges and devise solutions
- Understanding of the drug development process and governing regulations.
- Familiarity with cGMP and FDA/EMA requirements
Nice To Haves
- Direct experience overseeing CDMOs and external partners
- Formulation development experience
- Experience authoring regulatory CMC sections for regulatory filings
- Knowledge of FDA and ICH guidelines pertaining to drug product development and registration
Responsibilities
- Provide technical direction to Contract Development and Manufacturing Organizations (CDMO) for external Drug Product operations
- Develop formulations of oligonucleotide and oligonucleotide-conjugate drug products appropriate for the phase of pharmaceutical development
- Characterize drug product formulations to support clinical dosing and regulatory filings
- Review and approve batch records for use at CDMOs
- Author and execute formulation characterization protocols and author technical reports
- Draft and review technical documentation and leverage expertise to support regulatory filings
- Present data and technical information to intra- and inter-departmental colleagues and management
- Maintain a well-documented laboratory notebook.
- Track project deliverables and provide updates on progress to team members, management, and cross-functional teams.
- Coordinate delivery of materials both internally and externally
Benefits
- Arrowhead provides competitive salaries and an excellent benefit package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
