Senior Analytical Scientist (Chemistry)

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Senior Analytical Scientist (Chemistry) is responsible for managing the lifecycle of analytical methods. This includes the development, validation, and verification of methods to ensure the potency and stability of drug substances and products, maintaining high standards of quality and compliance. The role requires adherence to USP-NF Compendial testing standards, creating comprehensive validation reports, and generating Standard Operating Procedures (SOPs).

Essential Functions:

• Develop, validate, and verify USP-NF compendial testing for drug substances and drug products, ensuring compliance and reliability.
• Execute forced-degradation experiments to support method development and improve understanding of product stability.
• Write and execute method validation and verification protocols for UPLC/HPLC assays and other routine testing procedures, providing comprehensive reports.
• Conduct analytical method troubleshooting and lead discrepancy investigations to improve testing processes.
• Maintain strict adherence to USP-NF Compendial testing standards for injectable solutions and antibiotic standards, ensuring precise documentation.
• Develop and maintain Standard Operating Procedures (SOPs) related to chemical testing, ensuring clarity and regulatory compliance.
• Collaborate with the global Chemistry Team across sites on projects and continuous improvement initiatives, fostering innovation and teamwork.
• Performs other duties as assigned

Requirements

Required Qualifications & Experience:

• Bachelor's degree (in life sciences)
• 7+ years of Laboratory experience preferred

Desired Knowledge, Skills, and Abilities:

• Extensive experience in developing and validating UPLC/HPLC methods, particularly stability-indicating assays.
• Strong proficiency in executing forced-degradation studies and analytical troubleshooting.
• In-depth knowledge of USP-NF Compendial standards and regulatory requirements for chemical testing.
• Excellent project management skills, with the ability to drive continuous improvement initiatives.
• Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Understanding of USP/FDA and ICH regulations related to method development, validation, and verification.
• Communicate effectively with internal personnel, as well as external customers and vendors.

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.