MS&T Engineer – Media & Buffer Process Development

MS&T Engineer – Media & Buffer Process Development

Position: MS&T Engineer – Media & Buffer Process Development

Class:
Exempt

Reports to:

MS&T Manager/Director

Founded in 1985, Gemini Bio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life‑enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, Gemini Bio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin‑free cGMP manufacturing and animal component cGMP manufacturing.

Gemini Bio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

The MS&T Engineer – Media & Buffer Process Development is a hands‑on technical role responsible for translating customer and internal technical requirements into manufacturing‑ready, cGMP formulations and processes. This role owns the transition from development through engineering and first GMP manufacturing lots, ensuring scalable, robust, and compliant execution.

The MS&T Engineer works closely with Manufacturing, Quality, and Supply Chain to develop and transfer media, buffer, and bioprocess liquid formulations, author GMP documentation, and provide on‑the‑floor technical support during initial production runs.

This position requires strong fundamentals in bioprocess engineering, media and buffer formulation, and cGMP manufacturing, with the ability to operate effectively at the interface of development and manufacturing.

• Design, develop, and refine media, buffer, and bioprocess liquid formulations to support customer‑specific and internal manufacturing needs.
• Execute development and engineering studies to evaluate formulation robustness, scalability, and manufacturability.
• Apply principles of pH control, osmolality, raw material selection, mixing, and fluid handling to support industrial‑scale production.

• Lead the translation of customer and development requirements into GMP‑ready work instructions, batch records, and bills of materials.
• Execute and support development, engineering, and first GMP manufacturing lots, providing on‑the‑floor technical oversight during initial production runs.
• Transfer processes from internal development or external partners into Gemini Bio’s cGMP manufacturing facilities, ensuring facility fit and process alignment.
• Troubleshoot scale‑up, equipment, and process issues during manufacturing execution.

• Serve as a technical point of contact for Manufacturing, Quality, Supply Chain, and Project Management teams.
• Provide technical input to customer discussions, proposals, and feasibility assessments related to media and buffer manufacturing.
• Support investigations of deviations, nonconformances, and customer complaints through root‑cause analysis and corrective action development.
• Identify opportunities to improve product quality, process consistency, and manufacturing efficiency.
• Analyze process data to support long‑term optimization of Gemini Bio’s media and bioprocess liquid portfolio.
• Contribute to standardization and best practices across MS&T and manufacturing operations.

Customer Focus: Understands how scientific work impacts customer outcomes; integrates customer needs into development decisions.
Team

Collaboration:

Works effectively with diverse teams, contributing scientific insight while supporting collective goals.
Personal Leadership: Demonstrates accountability, initiative, and continuous improvement in technical…