Senior Scientist External Manufacturing API and Drug Product Support
Organon
August 25, 2026
On-site
Lower Gwynedd, PA
Operations
Responsibilities:
- Author analytical procedures, methods development/validation protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Perform investigations with strong troubleshooting skills; develop/implement Corrective Action and Preventative Actions (CAPA).
- Provide documentation/technical input during regulatory and internal inspections/audits; apply knowledge of data integrity and industry trends.
- Train staff on analytical techniques and problem solving; monitor regulation changes and support implementation of new strategies.
Required Education, Experience & Skills:
- BS or MS with at least 5 years’ experience, or PhD with at least 1 year.
- Hands-on analytical chemistry lab experience.
- Practical knowledge using liquid/gas chromatography and spectroscopic methods to support drug substance/product development, registration, and unknown peak identification.
- Experience collaborating with external providers; proficiency with regulatory filing requirements; effective cross-functional/interdisciplinary teamwork; strong verbal and written communication.
- Interpersonal skills, adaptability, cultural sensitivity; ability to tailor communication/coaching.
- Self-motivated ownership and accountability; speak up on issues, communicate risks, and drive resolution.
- Ability to adapt to change and manage risks; knowledge of API and/or drug product development/commercialization and commercial QC needs.
Preferred:
- LCMS, GCMS, NMR.
- Statistical software (e.g., Excel, Minitab).
- Basic proficiency with internal approved AI tools.
- Author analytical procedures, methods development/validation protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Perform investigations with strong troubleshooting skills; develop/implement Corrective Action and Preventative Actions (CAPA).
- Provide documentation/technical input during regulatory and internal inspections/audits; apply knowledge of data integrity and industry trends.
- Train staff on analytical techniques and problem solving; monitor regulation changes and support implementation of new strategies.
Required Education, Experience & Skills:
- BS or MS with at least 5 years’ experience, or PhD with at least 1 year.
- Hands-on analytical chemistry lab experience.
- Practical knowledge using liquid/gas chromatography and spectroscopic methods to support drug substance/product development, registration, and unknown peak identification.
- Experience collaborating with external providers; proficiency with regulatory filing requirements; effective cross-functional/interdisciplinary teamwork; strong verbal and written communication.
- Interpersonal skills, adaptability, cultural sensitivity; ability to tailor communication/coaching.
- Self-motivated ownership and accountability; speak up on issues, communicate risks, and drive resolution.
- Ability to adapt to change and manage risks; knowledge of API and/or drug product development/commercialization and commercial QC needs.
Preferred:
- LCMS, GCMS, NMR.
- Statistical software (e.g., Excel, Minitab).
- Basic proficiency with internal approved AI tools.