Senior Scientist External Manufacturing API and Drug Product Support
Organon
August 24, 2026
Remote friendly (Lower Gwynedd, PA)
United States
Operations
Responsibilities:
- Author analytical procedures, methods development and validation protocols/reports, technical reports, experimental designs, and regulatory submission documents.
- Perform investigations with strong technical troubleshooting; assist in developing/implementing Corrective Action and Preventative Actions.
- Provide documentation/technical input during regulatory and internal inspections/audits; apply working knowledge of data integrity and recent industry trends.
- Train staff as needed on analytical techniques and problem solving; stay current on regulation changes to support implementation of new strategies.
Required Education, Experience & Skills:
- BS or MS with at least 5 years of experience; PhD with at least 1 year of experience.
- Hands-on analytical chemistry lab experience.
- Practical knowledge developing/applying analytical techniques (liquid/gas chromatography and spectroscopic methods) for drug substance/product development, registration, and unknown peak identification.
- Collaborate with external service providers; proficiency in regulatory filing requirements; work effectively in cross-functional/interdisciplinary teams with strong verbal and written communication.
- Excellent interpersonal skills, adaptability, cultural sensitivity; ability to coach/tailor communication.
- Self-motivated; take ownership and drive issues to completion.
- Ability to raise issues, identify/communicate risks, and drive resolution; adapt quickly and plan for risk management.
- Knowledge of drug product and/or API development and commercialization; understand commercial quality control testing needs.
Preferred:
- LCMS, GCMS, NMR.
- Statistical software (e.g., Excel, Minitab).
- Basic proficiency with internal approved AI tools.
- Author analytical procedures, methods development and validation protocols/reports, technical reports, experimental designs, and regulatory submission documents.
- Perform investigations with strong technical troubleshooting; assist in developing/implementing Corrective Action and Preventative Actions.
- Provide documentation/technical input during regulatory and internal inspections/audits; apply working knowledge of data integrity and recent industry trends.
- Train staff as needed on analytical techniques and problem solving; stay current on regulation changes to support implementation of new strategies.
Required Education, Experience & Skills:
- BS or MS with at least 5 years of experience; PhD with at least 1 year of experience.
- Hands-on analytical chemistry lab experience.
- Practical knowledge developing/applying analytical techniques (liquid/gas chromatography and spectroscopic methods) for drug substance/product development, registration, and unknown peak identification.
- Collaborate with external service providers; proficiency in regulatory filing requirements; work effectively in cross-functional/interdisciplinary teams with strong verbal and written communication.
- Excellent interpersonal skills, adaptability, cultural sensitivity; ability to coach/tailor communication.
- Self-motivated; take ownership and drive issues to completion.
- Ability to raise issues, identify/communicate risks, and drive resolution; adapt quickly and plan for risk management.
- Knowledge of drug product and/or API development and commercialization; understand commercial quality control testing needs.
Preferred:
- LCMS, GCMS, NMR.
- Statistical software (e.g., Excel, Minitab).
- Basic proficiency with internal approved AI tools.