Executive Director of Biomanufacturing & Downstream Processing

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 Executive Director of Biomanufacturing and Downstream Processing is responsible for all cGMP protein manufacturing for both Drug Substance (DS) purification and Drug Product (DP) Fill & Finish at our multi-product clinical manufacturing facilities based in Sioux Falls, SD. Provides technical leadership and leads an operational team in bioprocessing, strategy, problem-solving and tactical execution conducted in compliance with regulatory and key business objectives for SAB. Leads and develops a team of manufacturing professionals to ensure delivery of final drug product and results by meeting production schedules and critical deadlines, and implementation of continuous process improvements that enhance operational efficiencies and quality performance of clinical and commercial manufacturing.

Ensures on-time product release of DS and/or DP and oversees clinical and commercial procurement/supply. Ensures manufacturing operations are in compliance with cGMP and all other applicable regulations and laws.

Scientific opportunity and intellectual enrichment attendant to these roles provide scope for developing new technical and scientific process/product implementations and providing technical and engineering support during feasibility, technical planning phase, process technology transfer, and launch - including commissioning, qualification, and validation lifecycle (CQV). Maintains quality standards ensuring that the facilities are compliant with regulatory and safety standards and possesses a thorough understanding of the technical and relevant processes and equipment to provide leadership in maintenance, troubleshooting, process evaluations, and critical decision-making.

Provides business leadership to manage the budgeting and planning processes for manufacturing effectively to ensure that customer, financial, and operational objectives are met. Leads change management initiatives. In addition, is capable of sourcing and developing external CDMO relationships and maintaining quality progression as needed.

Essential Duties and Responsibilities:

• Sets the vision, strategy and establishes priorities for the DS and DP Fill & Finish function in alignment with the strategic direction and focus for the Sioux Falls clinical manufacturing facilities, adjusting vision and priorities as necessary / in accordance with shifting business growth and needs.
• Leads and manages functional manufacturing teams to achieve facility production goals and objectives in a multi-product campaign environment. Ensures flexible, effective, efficient manufacturing according to production goals. Resolves any production related issues. Manages facility production scheduling and capacity analysis to ensure product is manufactured within schedule deadlines
• Function Responsibilities for DS – Purification, and DP – Fill & Finish:

• Provides technical leadership for the function: Antibody Purification and Fill and Finish
• Oversees technology transfer and process validation activities in close collaboration with Process Development, Quality Assurance, Quality Control, and other CMC associated teams.
• Oversees, either directly or indirectly, investigations and process deviations.
• Substantially involved in the development, revision and accuracy of the facility Production Schedule and Supply procurement.
• Partners with other functions to deliver key project cross-functional milestones including initiatives in facility, equipment and process improvements, integrated IT systems and data historian management and reporting.
• Participates on strategic initiatives such as tech transfer projects, partnership projects, and due diligence activities with business development.
• Leads technical and process changes in close collaboration with Quality, Regulatory and other involved functional teams.

• Provides functional leadership for all stages of the Manufacturing operation. Leads and develops the manufacturing management team and technical operators and ensures that the right skills and capabilities of people in the Manufacturing function are developed to enable the organization to be flexible/adapt to the dynamic business conditions for commercial and rapid response programs.
• Monitors and analyzes performance of manufacturing processes to ensure successful process validation, product launch, continuous process improvement, trouble shooting, facility fit, and deviation investigation/resolution for DS and DP.
• Identify and establish state-of-the-art technologies for large scale DS and DP manufacturing including asset management and investments.
• Demonstrates expertise of GMP, FDA and preferably European regulations. Follows all relevant department policies, procedures, SOPs and other requirements during manufacturing execution and acts at all times within the SAB standards/ethics policies.

Qualifications:
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.

Education, Experience and Certifications:

• M.S. or PhD from an accredited institution in engineering, biotechnology, biological / pharmaceutical sciences or related fields required.
• Five (5) years or more extensive expertise in DS and DP manufacturing. Broad experience in pharmaceutical manufacturing and/or packaging and a proven track record solving complex technical issues.
• Experience leading manufacturing teams to maintain adherence to a demanding production schedule, working with cross-functional teams, such as Quality, Regulatory, Process Development, R&D and Project Management.
• Skilled in strategic thinking, communication, negotiation, and fast decision making
• Experience with authoring and reviewing standard operating procedures, on-the-job-training, and other process manufacturing controlled documents
• Experience with quality systems such as deviation management, CAPA, and change control systems.
• Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment.
• Strong project management skills.
• Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management.

Leadership Skills:

· Requires excellent interpersonal, investigative and implementation skills.

· Ability to think strategically, strong business judgment connecting human resources with the business strategies and goals.

· Communicates a compelling vision and implements strategic plans for the manufacturing objectives.

· Provides the leadership to implement solutions to complex problems using the best available technology.

· Requires effective leadership performance management and coaching skills.

Technical Skills:

· Extensive technical skills in the area of large antibody purification, filling, assembly and/or packaging respectively.

· Experience in commercial pharmaceutical manufacturing, resource planning, scheduling and process implementation.

· Expertise in process transfer, scale-up, validation, trouble shooting, and launch of DP and DS.

· Experience in deviation and CAPA management

· Experience with regulatory filing and managing FDA audits

Language Skills:
Individual should possess strong communication skills and proficiency in Microsoft Office software (Word, Excel, PowerPoint, Project and Outlook) as well as the ability to effectively present information in one-on-one and small groups.

Mathematical Skills:
Basic mathematical skills to consist of addition, subtraction, multiplication and division. Able to calculate dilutions and molarity.

Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must be able to move up to 100 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.

Physical Requirements/Working Conditions: Job requires good physical mobility. Ability to move 100 pounds by mechanical means. Be able to sit for extended periods of time. Ability to wear aseptic gowning for extended periods of time.

Working Environment:
Duties will require on occasion activities performed in normal laboratory, ISO 7 environment, BSL2 laboratory settings and aseptic environments (ISO5).
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.