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SCA Pharma · 1 month ago

Formulation Scientist

United States

Full-time

Remote

Senior Level

5+ years exp

SCA Pharmaceuticals is a dynamic rapidly growing company focused on providing high-quality medications critical for saving and sustaining human life. The Formulation Scientist is responsible for developing and optimizing sterile injectable formulations, ensuring compliance with FDA and cGMP requirements while collaborating with cross-functional teams to support product development and scale-up.

Health CarePharmaceutical

Responsibilities

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

Qualification

Pharmaceutical formulation developmentSterile injectablesCGMP complianceQuality by Design (QbD)Design of Experiments (DOE)Regulatory documentationStatistical softwareProject managementTechnical writingCommunication skills

Required

Master's degree in biology, chemistry, engineering, or related field—or equivalent experience

5+ years in pharmaceutical formulation development

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 (795, 797, 800), 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