Senior Manager, Process Development

Doist; Verona (WI); On-site; USD 120,000 - 135,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison/Verona, WI is seeking a Senior Scientist to lead a team of chemists in scalable manufacturing process development for oligonucleotides.

Responsibilities include directing the team, optimizing synthesis and downstream steps, reviewing batch records, and supporting technology transfer to manufacturing. The candidate will apply expertise in solid-phase synthesis, analytical techniques, and cGMP practices to deliver robust processes for clinical candidates

Qualifications

• Direct experience with solid-phase oligonucleotide synthesis and downstream processes.
• PhD with 4+ years, or MS with 10+ years, or BS with 12+ years of relevant experience.
• Excellent verbal and written communication skills.
• Familiarity with cGMP manufacturing processes and regulatory requirements.
• Experience with technology transfer and scale-up.

Responsibilities

• Provide technical direction to a team of associate chemists in oligonucleotide process development.
• Develop and optimize solid-phase oligonucleotide synthesis and downstream steps.
• Review batch records for upcoming manufacturing campaigns.
• Support internal manufacturing with process troubleshooting and deviations.
• Implement process improvements to enhance yield, purity, and throughput.
• Plan laboratory-scale studies, scale-up activities, and characterization work.
• Collaborate with analytical development, manufacturing science, quality, and regulatory teams.
• Support technology transfer of developed processes to manufacturing.
• Utilize analytical techniques to characterize products and impurities.
• Deliver multigram scale batches of siRNA and conjugates for nonGMP activities

Skills

Oligonucleotide synthesis

Process development

Team leadership

Scientific communication

Analytical methods

Problem solving

Education

PhD in Chemistry or related field

MS in Chemistry or related field

BS in Chemistry or related field

Tools

Cytiva instrumentation

Unicorn software

Job 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 role described herein is for a Senior Scientist to lead a team of chemists in the development of scalable manufacturing processes for oligonucleotides. The role is within the CMC Developmental Chemistry Department’s Process Development organization. Responsibilities of the position include scientific support for onsite manufacturing, design and implementation of process improvements, and development of oligonucleotide synthesis and downstream processes to support the manufacture of 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 workload allocation 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 in support of upcoming manufacturing campaigns
• Provide scientific and technical support to internal manufacturing team, including process troubleshooting and deviation investigation
• Implement process improvements that 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 nonGMP activities
• Demonstrate flexibility with changing priorities

Requirements

• PhD. with at least 4+ years, or M.S. with at least 10+ years, or B.S. with at least 12+ years of relevant industrial or academic experience, in Chemistry or 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: Familiarity with process scale-up, technology transfer, and the translation of 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

Wisconsin pay range $120,000 — $135,000 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.

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