Scientist III, Process Development

Arrowhead Pharmaceuticals•Verona, WI

1d•$110,000 - $120,000

About The Position

This position is part of the Process Chemistry function within Developmental Chemistry 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 externally manufactured drug substance batches and provides technical stewardship for tech transfer, monitoring, trending, and communication of critical batch data to support process improvements. The role collaborates closely with Analytical Development, Discovery, Regulatory, Quality, and Manufacturing. A strong GMP background and experience with active pharmaceutical ingredient (API) manufacturing are expected. Experience providing technical guidance in downstream process chemistry and manufacturing support for antibody-oligonucleotide conjugates (AOCs) or oligonucleotides is preferred. The position is being hired at the Scientist III level, but depending on a candidate’s education and experience, may be hired at Scientist II.

Requirements

Ph.D. in Chemistry with relevant industry experience; or a master’s degree in chemistry with 10+ years of relevant industry experience; or a bachelor’s degree in chemistry with 12+ years of relevant industry experience.
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.

Nice To Haves

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.

Responsibilities

Serve as the technical lead for one or more externally manufactured programs and provide technical stewardship throughout the product lifecycle.
Perform detailed technical reviews of pre-production master batch records, executed batch records, and batch-disposition documentation.
Track and trend key process parameters throughout the product lifecycle, including mass balance, in-process testing (IPC), critical impurities, critical quality attributes (CQAs), and batch variability.
Monitor and communicate trends to Process Team members and partner with the team to define and implement improvements that enhance batch consistency, quality, and yield.
Lead root-cause investigations related to manufacturing deviations, batch failures, and technical issues, and support implementation of appropriate corrective actions.
Coordinate internal oligonucleotide manufacturing activities to ensure batch supply aligns with external vendor requirements for conjugation.
Partner with the Process Development team during technical transfer of new programs to external vendors to ensure effective transfer of process knowledge.
Act as the primary technical point of contact for externally manufactured batches, troubleshoot deviations and out-of-specification (OOS) results, and partner with Process Development to resolve technical issues.
Execute scale-up conjugations in the process development lab to support internal GLP batches.
Collaborate with other process development team members and execute bench-scale reactions as needed.
Perform all job responsibilities in accordance with safety and regulatory expectations, including current Good Manufacturing Practices (cGMP).
Perform other duties as assigned.