Principle Analytical Scientist

Description

Company Description

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 Principal Analytical Scientist is a senior-level role, responsible for developing, implementing, and overseeing analytical strategies and methods for characterizing various materials and products. The Senior Principal Analytical Scientist is responsible for leading and directing activities related to the lifecycle of analytical methods. They are responsible for driving the analytical strategy, developing and implementing control strategies, and providing technical leadership in the development of new analytical methodologies. This includes the development, validation, and verification of methods to ensure the quality of drug substances and products, maintaining high standards of compliance. The role requires adherence to USP-NF Compendial testing standards, creating comprehensive validation reports, and generating Standard Operating Procedures (SOPs). This role reports to the Director of Quality Control. 

Essential Functions: 

• Define and implement the overall analytical strategy for drug development projects, including method development, validation, and control strategies.
• Drive innovation in analytical workflows and leading process improvement initiatives.
• Develop, validate, and verify USP-NF compendial testing for raw materials/components, APIs, drug substances, and drug products, ensuring compliance and reliability.
• Execute forced-degradation experiments to support method development and improve understanding of product stability.
• Investigating and resolving complex analytical issues, troubleshooting analytical methods, and implementing corrective actions. 
• 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.
• Provide technical leadership and guidance to analytical teams, mentoring junior scientists, and fostering a culture of scientific excellence.
• 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); advanced degrees (e.g., MS or PhD) in Analytical Chemistry, Biochemistry, or a related field is preferred

Extensive experience (10+ years of laboratory experience) in analytical development, method development and validation, and regulatory requirements within the pharmaceutical or biotechnology industry.

Desired Knowledge, Skills, and Abilities:

Proven ability to lead teams, mentor junior scientists, and manage complex projects.

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.

Possess deep technical knowledge and hands-on experience with relevant analytical techniques (e.g., HPLC, GC, Mass Spectrometry, spectroscopy, etc.)

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.

Excellent written and verbal communication skills to effectively communicate scientific information to diverse audiences

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.