Formulation Scientist

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.

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:

• Masters degree in biology chemistry engineering or related fieldor equivalent experience
• 5 years in pharmaceutical formulation development; experience in sterile compounding or aseptic manufacturing preferred
• Strong knowledge of formulation science and excipients for sterile injectables
• Experience with sterile and compounded dosage forms
• Working knowledge of cGMP compliant Quality Systems and FDA regulations including 21 CFR Part 503B USP compounding standards () and 21 CFR Parts 210 and 211
• Proficiency with Quality by Design (QbD) principles and Design of Experiments (DOE) methodologies
• Strong project management leadership and problem-solving abilities
• Proven ability to communicate and collaborate across teams
• Proficient in MS Office and statistical software

Desired Knowledge Skills and Abilities:

• Experience with regulatory documentation and technical writing for 503B compliance.
• Understanding of risk management principles and failure mode effects analysis (FMEA).
• Ability to communicate complex scientific concepts to diverse audiences.
• Must be well organized and detail-oriented with proven initiative and self-starter skills.

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.