Materials scientist serp_jobs.h1.location_city

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 problem solving.

Summary :

The Formulation Scientist is responsible for developing and optimizing sterile injectable formulations for 503B compounding operations. This role focuses on formulation design, scale-up, and technical support to ensure stability, manufacturability, and compliance with FDA and cGMP requirements. Key responsibilities include conducting compatibility and stability studies, preparing technical documentation for 503B compliance, and collaborating with cross-functional teams to support product development and scale-up. The Formulation Scientist provides formulation expertise during investigations and regulatory inspections as needed and contributes to new product initiatives and lifecycle management.

Requirements

Essential functions :

• Lead the design and development of pharmaceutical formulations for sterile injectables in compliance with FDA and cGMP standards.
• Scale up lab formulations to commercial production, ensuring reproducibility and robust results. Support evaluation of technologies and processes to improve product performance.
• Conduct compatibility studies using stability testing and chromatographic techniques.
• Develop and optimize formulations to ensure stability and manufacturability.
• Evaluate and select appropriate pharmaceutical API and excipients based on functionality, compatibility, and regulatory status.
• Provide formulation support to troubleshoot manufacturing challenges.
• Prepare formulation development reports and technical documentation to support 503B compliance.
• Provide technical support during regulatory inspections as needed.
• Support investigations and provide formulation input for deviations and change controls.
• Collaborate with cross-functional teams to support product development and scale-up.
• Provide formulation input for new product development initiatives.
• Additional responsibilities as assigned.

Required Qualifications & Experience :

Desired Knowledge, Skills, and Abilities :

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.