Vice President, Manufacturing

🕒 July 27

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SAB BIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies to treat and prevent immune and autoimmune disorders, with a stated mission to redefine diagnosis and treatment of type 1 diabetes (T1D) through disease-modifying medicines. Founded in 2014 and traded on Nasdaq (SABS) since 2021, SAB BIO uses proprietary genetic engineering and antibody technologies to generate therapeutic candidates without relying on human donors or convalescent plasma. The company has conducted seven clinical trials dosing roughly 700 individuals across multiple therapeutic areas, reporting no patients with serum sickness or neutralizing anti-drug antibodies in its safety and immunogenicity database. Its lead candidate, SAB-142, is aimed at delaying onset and potentially preventing progression of Stage 3 T1D.

📋 Description

• Provide strategic, operational, and technical leadership for the company’s manufacturing activities. • Establish scalable, compliant, and cost-effective manufacturing capabilities. • Lead manufacturing network strategy, CDMO management, technology transfer, scale-up, process validation, operational readiness, and reliable commercial supply. • Ensure that manufacturing operations meet global regulatory expectations and maintain a strong culture of safety, quality, compliance, and continuous improvement. • Develop and execute the overall manufacturing strategy supporting late-stage clinical development and commercial launch readiness. • Provide executive leadership and oversight of CDMO partners supporting bulk process intermediates and drug product manufacturing activities. • Oversee technology transfer of manufacturing processes to external partners and support scale-up from development through commercial production. • Ensure successful execution of cGMP manufacturing campaigns supporting clinical supply and future commercial supply.

🎯 Requirements

• Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline preferred. • Advanced scientific degree strongly preferred. • 15+ years of progressive experience in biologics manufacturing, technical operations, CMC, or pharmaceutical operations. • Significant experience leading GMP manufacturing operations and managing outsourced biologics manufacturing through CDMOs. • Demonstrated success supporting late-stage clinical programs. • Experience leading technology transfer, process validation, scale-up, and commercial readiness for immunoglobulin-based or protein-based products. • Expertise in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or analogous large-scale separation and purification processes is desired. • Proven track record contributing to global regulatory filings and CMC documentation. • Experience supporting BLA submissions, pre-approval inspections, regulatory inspections, and commercial launch readiness activities strongly preferred. • Strong experience building and leading high-performing technical teams.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development