Sioux Falls, South Dakota, United States · Hybrid
$275k–$310k/yr
The VP of Quality Assurance (VP QA) is a key executive leader responsible for building, scaling, and overseeing SAB’s global Quality Assurance organization as the company advances from late‑stage clinical development tow…
Skills: Quality Assurance, GxP Compliance, Regulatory Affairs, Strategic Leadership, Clinical Development
Sioux Falls, South Dakota, United States · On-site
The Research Associate 1 PDM, specializing in process development and purification, will be primarily responsible for supporting protein purification processes and equipment maintenance in the Process Development and Pur…
Skills: Protein purification, Laboratory maintenance, Chromatography software, Buffer preparation, Equipment calibration
Sioux Falls, South Dakota, United States · On-site
The Quality Assurance Manager is a key member of SAB Biotherapeutics’ Quality Assurance function and is responsible for supporting and maintaining an inspection-ready Quality Management System across SAB’s biologics, cli…
Skills: Quality Assurance, Quality Management System, GxP, cGMP, Regulatory Compliance
Sioux Falls, South Dakota, United States · Remote OK
$295k–$315k/yr
The Executive Director, Pharmacovigilance (PV) is a senior individual contributor and team leader who will serve as a cornerstone of the company's global drug safety function. This role has end-to-end accountability for …
Skills: Pharmacovigilance, Global Safety Surveillance, Aggregate Safety Reporting, Signal Detection, Regulatory Submissions
Sioux Falls, South Dakota, United States · On-site
The Sr. QA Specialist leads key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. With over five years of experience, this role manages complex investigations, ove…
Skills: cGMP Compliance, Quality Assurance, CAPA Management, Change Control, Deviation Investigations
Miami Beach, Florida, United States · Remote OK
$150k–$165k/yr
The Clinical Trial Manager (CTM) oversees the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines. The CTM plays a …
Skills: Clinical Trial Management, CRO Management, Protocol Design, Budget Tracking, GCP Compliance
Sioux Falls, South Dakota, United States · Hybrid
$285k–$315k/yr
The Vice-President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at SAB Biotherapeutics (SAB). This role will lead preparation, review and submission of docume…
Skills: Regulatory Affairs, FDA Liaison, BLA Submission, MAA Submission, IND Application
Sioux Falls, South Dakota, United States · On-site
The Quality Management System (QMS) Specialist is responsible for the administration, maintenance, and continuous improvement of the company’s Quality Management System to ensure compliance with current Good Manufacturin…
Skills: Quality Management Systems, cGMP, GxP, Document Control, Change Control
Sioux Falls, South Dakota, United States · Remote OK
$300k–$340k/yr
The VP Manufacturing will provide strategic, operational, and technical leadership for the company’s manufacturing activities supporting late-stage clinical development, commercial readiness, and future commercial supply…
Skills: Biologics Manufacturing, CDMO Management, CMC Documentation, Technology Transfer, Process Validation
Sioux Falls, South Dakota, United States · Remote OK
$190k–$260k/yr
The Sr. Director, Medical Writing – Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage d…
Skills: Medical Writing, Biologics Regulatory Writing, BLA Submission, MAA Submission, Clinical Study Reports
Sioux Falls, South Dakota, United States · Remote OK
$190k–$260k/yr
The Sr. Director, Medical Writing – Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage d…
Skills: Medical Writing, Biologics Regulatory Writing, BLA Submission, MAA Submission, Clinical Study Reports
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The VP of Quality Assurance will define and drive the company's global QA strategy, ensuring scalability and compliance as the organization transitions toward commercialization. This role oversees all GxP functions, manages inspection readiness, and partners with cross-functional teams to ensure regulatory expectations are met.
Candidates must possess a bachelor's degree in a scientific discipline with 15+ years of progressive quality leadership experience in the pharmaceutical or biotech industry. Proven success in leading global regulatory submissions and managing audits with authorities like the FDA and EMA is required.
Working to transform treatment for people living with type 1 diabetes through a unique disease-modifying therapy
At SAB BIO, our mission is to dramatically redefine what it means to be diagnosed with type 1 diabetes (T1D) by developing a medicine to change the course of disease, not just treat symptoms. SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company was founded in 2014 and traded on Nasdaq (SABS) since 2021. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. To date, SAB BIO has conducted seven clinical trials that have dosed 700 individuals across multiple therapeutic areas. The safety and immunogenicity database for these trials shows zero patients with serum sickness or neutralizing anti-drug antibodies, which suggests an improved safety profile over other therapies. SAB BIO’s lead product candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.
Offices: Miami, FL , US · Sioux Falls, South Dakota, US
Working to transform treatment for people living with type 1 diabetes through a unique disease-modifying therapy
At SAB BIO, our mission is to dramatically redefine what it means to be diagnosed with type 1 diabetes (T1D) by developing a medicine to change the course of disease, not just treat symptoms. SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company was founded in 2014 and traded on Nasdaq (SABS) since 2021. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. To date, SAB BIO has conducted seven clinical trials that have dosed 700 individuals across multiple therapeutic areas. The safety and immunogenicity database for these trials shows zero patients with serum sickness or neutralizing anti-drug antibodies, which suggests an improved safety profile over other therapies. SAB BIO’s lead product candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.
Offices: Miami, FL , US · Sioux Falls, South Dakota, US
