Senior Analytical Scientist (Microbiology)

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 sustain 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 (Microbiology) will play a pivotal role in leading and executing method suitability projects for USP 71, as well as method verification and validation. This position involves onboarding new technology and managing antibiotic testing processes. The role requires adherence to USP-NF Compendial testing standards, creating comprehensive validation reports, supporting contamination investigations, and generating Standard Operating Procedures (SOPs).

Lead method suitability projects for USP 71, ensuring best practices in method verification and validation.

Oversee the onboarding of new technology and the implementation of antibiotic testing protocols.

Ensure strict adherence to USP-NF Compendial testing for injectable solutions and antibiotic standards, developing comprehensive validation reports and maintaining accurate documentation.

Support contamination investigations by providing expert analysis, influencing decision-making processes to enhance product safety and quality.

Develop and maintain SOPs related to microbiological testing, ensuring clarity and compliance with regulatory requirements.

Engage with the global Microbiology Team across sites on projects and continuous improvement initiatives.

Other additional job-related duties as required

Bachelor s degree (in life sciences)

7 years of Laboratory experience preferred

Extensive expertise in microbiological method development, with a strong understanding of USP-NF Compendial testing.

Preferred experience with Celsis Rapid Sterility Testing to enhance testing efficiency and reliability.

Demonstrated knowledge and application of Aseptic Technique, ensuring contamination control and product integrity.

Strong project management skills with the ability to influence outcomes and drive continuous improvement initiatives.

Excellent communication skills to effectively collaborate with team members and engage with stakeholders across different sites.

Ability to work independently on complex scientific projects, providing leadership and direction to support laboratory goals.

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.