The PositionThis 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.
Wisconsin pay range
$85,000-$95,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
