Scientist I, Early Phase Process Development

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 160,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Process Chemistry Scientist to provide technical oversight for externally manufactured drug substance programs within the CMC function.

The role leads documentation for external batches and monitors batch data to support process improvements. The successful candidate will have a strong GMP background, experience with API manufacturing and early-phase drug substance production, and will partner with Analytical Development, Regulatory,

Qualifications

• Master’s degree with 5+ years industry experience; or Bachelor’s with 8+ years experience.
• Experience in pharmaceutical/biotech process development or drug substance manufacturing.
• Experience with cGMP and regulatory documentation reviews.

Responsibilities

• Provide technical oversight for externally manufactured drug substance programs.
• Review master batch records, executed batch records, and batch-disposition docs.
• Track key process parameters and trends for lifecycle improvements.
• Lead root-cause investigations and implement corrective actions.
• Coordinate with CMOs and Process Development for tech transfer.
• Ensure compliance with cGMP and safety requirements.

Skills

GMP documentation review

Data analysis

Root-cause investigations

Cross-functional collaboration

Technical communication

Problem solving

Process development

Education

Master’s degree in Chemistry/Biochemistry/Chemical Engineering/Pharmaceutical Sciences

Bachelor’s degree with 8+ years industry experience

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 Position

This position is part of the Process Chemistry function within CMC and provides technical oversight and lifecycle management for drug substance candidates manufactured by external contract manufacturing organizations (CMOs). The Scientist serves as the technical lead for documentation associated with externally manufactured drug substance batches and as the technical steward responsible for monitoring, trending, and communicating critical batch data to support process improvements. The role collaborates closely with Analytical Development, Discovery, Regulatory, Quality and Manufacturing. The successful candidate will have a strong GMP background, experience with active pharmaceutical ingredient (API) manufacturing, and a comprehensive understanding of early-phase drug substance manufacturing. Experience providing technical guidance and manufacturing support for antibody-oligonucleotide conjugates (AOCs) or oligonucleotides is preferred.

Responsibilities

• Serves as the technical lead for one or more externally manufactured programs and provides technical stewardship throughout the product lifecycle.
• Performs detailed technical reviews of pre-production master batch records, executed batch records, and batch-disposition documentation.
• Tracks and trends key process parameters throughout the product lifecycle, including mass balance, in-process testing (IPC), critical impurities, critical quality attributes (CQAs), and batch variability.
• Monitors and communicates trends to Process Team members and partners with the team to define and implement improvements that enhance batch consistency, quality, and yield.
• Leads root-cause investigations related to manufacturing deviations, batch failures, and technical issues, and supports the implementation of appropriate corrective actions.
• Coordinates internal oligonucleotide manufacturing activities to ensure batch supply aligns with external vendor requirements for conjugation.
• Partners with the Process Development team during the technical transfer of new programs to external vendors to ensure effective transfer of process knowledge.
• Acts as the primary technical point of contact for externally manufactured batches, troubleshoot deviations and out-of-specification (OOS) results, and partners with Process Development to resolve technical issues.
• Execute scale-up conjugations in the process development lab to support internal GLP batches.
• Collaborates with other process development team members and executes bench scale reactions on an as needed basis.
• Performs all job responsibilities in accordance with safety and regulatory expectations, including current Good Manufacturing Practices (cGMP).
• Other duties as assigned.

Requirements

• Master’s degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific field and at least 5 years of relevant industry experience; or bachelor’s degree in a related scientific field and at least 8 years of relevant industry experience. An equivalent combination of education and experience may be considered.
• Experience in pharmaceutical or biotechnology process development, drug substance manufacturing, or a related technical function.
• Working knowledge of current Good Manufacturing Practices (cGMP) and applicable pharmaceutical regulatory requirements.
• Experience reviewing technical or GMP documentation, such as master batch records, executed batch records, development reports, deviations, or investigations.
• Demonstrated ability to analyze process data, identify trends, troubleshoot technical issues, and support root-cause investigations.
• Strong written and verbal communication skills, including the ability to clearly communicate technical information.
• Strong problem-solving, organizational, and cross-functional collaboration skills.

Preferred

• Experience working with contract manufacturing organizations (CMOs) and/or supporting oligonucleotide or antibody-oligonucleotide conjugate (AOC) development or manufacturing.
• Experience in the manufacture or development of antibody-oligonucleotide conjugates (AOCs) or oligonucleotides.

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.