Senior Scientist External Manufacturing API and Drug Product Support

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Analytical Chemist to lead analytical development and validation activities for drug substance and product programs in Pennsylvania. The role focuses on method development, data integrity, and regulatory support, collaborating with internal teams and external service providers.

The candidate will bring hands-on LCMS/GCMS/NMR expertise, strong problem-solving skills, and the ability to communicate technical concepts clearly in cross-functional settings,

Qualifications

• BS or MS in chemistry with 5+ years experience; PhD with at least 1 year experience.
• Hands-on analytical chemistry lab experience.
• Practical knowledge developing/applying analytical techniques (LC/GC/MS, NMR) for drug substance/product development, registration, and impurity identification.
• Collaborate with external service providers; regulatory filing knowledge; work in cross-functional teams with strong 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; plan for risk management.
• Knowledge of drug product and/or API development and commercialization; understand QC testing needs.

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.
• Train staff on analytical techniques and problem solving; stay current on regulation changes to support implementation of new strategies.

Skills

Analytical chemistry

Regulatory filing experience

Cross-functional collaboration

Communication skills

Education

BS or MS in Chemistry

PhD in Chemistry

Tools

LCMS

GCMS

NMR

Excel / Minitab

Job description

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.