Senior Manager, Process Development

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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 (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, leveraging RNAi technologies to address conditions across virtually any therapeutic area, including targets not addressable by small molecules and biologics. Arrowhead’s clinical pipeline includes disease targets in the liver and lung, with a promising preclinical pipeline.

About the role

This position is for a Senior Scientist to lead a team of chemists in developing scalable manufacturing processes for oligonucleotides within the CMC Developmental Chemistry Department’s Process Development organization. The role involves scientific support for onsite manufacturing, process improvements, and development of oligonucleotide synthesis and downstream processes to support new therapeutic candidates and delivery platforms.

Responsibilities

• Provide technical direction to a team of associate chemists engaged in oligonucleotide process development, set project priorities, and allocate workload to meet project timelines.
• Develop and optimize solid-phase oligonucleotide synthesis and downstream processes, including cleavage, deprotection, purification, desalting, annealing, isolation, and bioconjugation in support of new clinical candidates.
• Provide technical review of batch records for upcoming manufacturing campaigns.
• Offer scientific and technical support to the internal manufacturing team, including process troubleshooting and deviation investigation.
• Implement process improvements to enhance yield, purity, throughput, robustness, or safety of manufacturing existing clinical candidates.
• Plan and execute laboratory-scale studies, scale-up activities, and process characterization work, ensuring experiments are well-documented and reproducible.
• Collaborate with analytical development, manufacturing science and technology, quality, regulatory, and program management to align process development activities with program objectives.
• Support technology transfer of newly developed processes from development into manufacturing.
• Utilize analytical techniques to characterize products and product-related impurities.
• Deliver multigram-scale batches of siRNA and siRNA conjugates to support non-GMP activities.
• Demonstrate flexibility with changing priorities.

Requirements

• Ph.D. with at least 4+ years, M.S. with at least 10+ years, or B.S. with at least 12+ years of relevant industrial or academic experience in Chemistry or a related field.
• Direct experience with solid-phase oligonucleotide synthesis and downstream processes.
• Excellent verbal and written communication skills.
• Excellent problem-solving skills.
• Expertise in synthetic organic chemistry and relevant analytical technology.

Preferred Qualifications

• Familiarity with process scale-up, technology transfer, and translating laboratory-scale chemistry into robust, cGMP-compliant manufacturing processes.
• Experience with Cytiva instrumentation and Unicorn software, particularly OP100, Oligosynt, and Avant.
• Familiarity with cGMP and regulatory requirements.
• Experience with oligonucleotide conjugation chemistry.

Pay

Wisconsin pay range: $120,000 USD - $135,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.