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 Company Profile Founded in 1985, GeminiBio 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, GeminiBio 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. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820. Position Summary 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. Key Responsibilities Media, Buffer & Bioprocess Liquid Development 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. Manufacturing Sciences & Technology Transfer 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 GeminiBio’s cGMP manufacturing facilities, ensuring facility fit and process alignment. Troubleshoot scale‑up, equipment, and process issues during manufacturing execution. Cross‑Functional & Customer Collaboration 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 GeminiBio’s media and bioprocess liquid portfolio. Contribute to standardization and best practices across MS&T and manufacturing operations. Core Competencies 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 skill and execution. Planning & Organization: Structures experiments and project tasks with foresight, anticipating challenges and adjusting plans proactively. Effective Communication: Clearly communicates scientific data, rationale, and recommendations to both technical and non‑technical audiences. Company Values Integrity Doing the right thing – the first time. Honoring and keeping commitments. Intensity Working with speed and focus to deliver the highest quality results – on time. Involvement Embracing unique perspectives and treating others with dignity and respect. Innovation Biased to improve processes and products to better serve customers and improve workflows. Required Skills and Experience BS or MS in Chemical Engineering, Bioprocess Engineering, or a related discipline. Hands‑on experience with media, buffer, or bioprocess liquid formulation in a regulated or manufacturing environment. Working knowledge of cGMP principles, documentation, and manufacturing controls. Experience supporting process development, scale‑up, tech transfer, or MS&T activities. Demonstrated experience with single‑use bioprocess containers (BPCs), sterile transfer assemblies, and industrial‑scale mixing systems. Basic understanding of fluid dynamics and heat transfer as applied to large‑scale liquid manufacturing. Ability to analyze data, troubleshoot process issues, and communicate conclusions effectively. Proficient with Microsoft Word and Excel; familiarity with statistical or data‑analysis tools is a plus. #J-18808-Ljbffr