Senior Director of Quality Control
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal.
Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Senior Director of Quality Control (QC) is a product quality leadership position providing scientific and technical expertise and is responsible for the strategic development of QC and validation functions for clinical through commercial stage cGMP products. Oversees analytical labs, microbiology, raw material testing, and stability testing programs. Also responsible for ensuring successful and timely completion of in-process and release testing deliverables. Requires considerable judgment and skills to identify and rectify test method challenges and make recommendations for corrective action necessary to assure conformity with quality specifications and cGMP regulatory compliance. This position works closely Manufacturing Operations and Quality Assurance to develop and maintain a comprehensive QC program and Project Management to assist in project planning and timeline development. The incumbent will be responsible developing employees and expanding the QC team managing new hires and operating the QC program within project and department budgets.
Essential Duties and Responsibilities:
- Lead QC department in designing programs and implementing actions to meet late stage cGMP and commercial compliance in areas such as: Analytical Assay Validation, Method validation to support technical transfer activities, Equipment and Software Validation, Reference Standard Characterization and implementation into assays, Stability Study Program, Raw Material Testing, QC Department Risk Assessments, Laboratory Information Management System (LIMS)
- Oversee and implement the overall analytical strategy for SAB testing, plasma qualification, in-process testing, release testing and raw material testing. This includes but is not limited to: Directing QC group managers and staff as appropriate, Supports QC organization during release, stability, and in-process testing, and inspections and audits of the QC organization, Equipment maintenance and calibration, and laboratory maintenance. May be involved in laboratory design, GMP material testing program, Assay Control, Reference Standard and OOS.
- Key member of the quality management team and provides both management and leadership to a team of technical professionals and administrative staff.
- QC budgeting including defining materials, equipment and personnel needs. Provides long-term planning of QC lab capabilities and capacity. Responsible for the implementation of new technologies.
- Signature authority for all Quality Control documents and data, including Certificates of Analysis.
- Active participant in the management and direction of the overall corporate Quality Program as it relates to internal and external programs and requirement.
- Ensure production support and cGMP compliance
- Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
- Designing test sample specifications
- New assay development
- Coordinating testing with outside collaborators
- Outside vendor audits
- Aid in communication with regulatory agencies – written responses, IND submissions etc.
- Lead QC department in incorporating quality systems and regulatory guidelines.
- Aid in the resolution of QC laboratory investigations.
- Review QC department SOP’s, Protocols, Reports, Deviations, Out of Specification Investigations and Programs.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
- Understanding of quality system applications, including the training, deviations, CAPA management, etc.
- Understand requirements pertaining to aseptic manufacture of antibody products.
- Strong understanding of Tech Transfer and Method Validation
- Ability to work effectively with clients in a contract manufacturing environment.
- Familiarity with the product development process for biological products is helpful.
- Ability to recruit, lead and develop a high-performance manufacturing organization.
- Strong written and oral communication skills
- Strong attention to detail, ability to work well independently and as a part of a team.
- Wiliness to positively embrace change and flexibility in adjusting to changing priorities
- Excellent communication and developed organizational skills.
- Excellent leadership skills required to head a QC team of technical professionals which includes; microbiology, raw materials and stability.
Education, Experience and Certifications:
- PhD or graduate-level degree (preferred) in a scientific discipline in biotechnology, pharmaceutical.
- Minimum of 5 years of relevant experience of which at least 3 years in a management experience in a cGMP regulated industry overseeing a laboratory environment with applicable clinical or commercial experience.
- Experience with environmental monitoring and aseptic processing is preferred.
- Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
- Experience in organizing and leading teams.
- Experience participating in health authority inspections and/or client audits.
Individual should possess effective communication skills and developed organizational skills. This position also requires basic proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook) as well as the ability to effectively present information in one-on-one and small groups.
Basic mathematical skills to consist of addition, subtraction, multiplication and division.
Physical Requirements/Working Conditions:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must be able to lift and/or move up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.