JOB SUMMARY

The Sr. Director, MS&T is responsible for establishing the KBI North Carolina (NC) Manufacturing Science & Technology (MS&T) organization to support the clinical, late-stage, and commercial supply of Drug Substances at the Hamlin Site and Patriot Park Site. This position will ensure a reliable, sustainable, high-quality supply chain of products to the clients at an optimized cost to the business. The position's main responsibility is to lead all manufacturing and technical service activities and customer interaction, including manufacturing technical support and process optimization, scale-up, technology and knowledge transfer, validation, and commercial manufacturing support.

The Sr. Director, MS&T, will liaise with clients, partner organizations and KBI Global MS&T to transfer and support new product introduction, resupply campaigns, improvements, innovation, troubleshooting, investigation, and commercialization of manufacturing processes and analytical methods.

The Sr. Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality Assurance, Quality Control, Regulatory, Supply Chain, Manufacturing, and our clients to ensure all aspects of manufacturing operations and technical services are successfully executed efficiently and in a timely manner. In addition, the position is responsible for establishing systems for managing process information and for data analytics used for investigations, manufacturing process optimization, and data reporting.

The Sr. Director should demonstrate proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices. The scope of this role includes:

• Functional Leadership for MS&T strategy, organizational management, processes and performance management

• Is responsible for facility fit assessment, technology transfer activities, coordination of process start-up activities, including Engineering Runs, GMP/clinical, Resupply, PPQ, and routine commercial runs, and resulting risk mitigation activities.

• Support the authoring, reviewing, and approving of regulatory applications for customers, as well as support responses to regulatory agencies. Review and/or approve internal and CMC documents and relevant sections of regulatory filings (IND, BLA, etc.) and responses. Remain current on Health Authority guidance and expectations.

• Drive new commercial product introduction and process validation from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI)

• Develop risk-based strategies for process validation of commercial products and ensure application of these requirements throughout the product lifecycle.

• Drive new clinical product introduction to ensure successful tech transfer through collaboration with Process Development and establish and maintain the procedures, business processes, and tools/systems for tech transfer.

• Lead phase-appropriate risk-based qualification strategies for manufacturing process steps and support analytical methods for in-process testing, release, characterization, and stability, aligned with the goal of commercialization and ensuring application of these requirements throughout the product lifecycle.

• Drive standards and industry best practices to ensure organizational efforts are scalable and sustainable across sites

• Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management.

• Responsible for complex process related manufacturing investigations and providing technical evaluations for deviation investigations, corrective and preventative actions, and change controls

• Lead multi-disciplinary projects and strategic oversight for robust manufacturing operations, facility designs, new technology implementation, production revenue growth, cost of goods optimization and streamlined practices.

• Develop budget plans and recommend staffing requirements to meet departmental goals. Monitor department expenses and make recommendations on departmental capital budget items.

JOB RESPONSIBILITIES

The candidate must apply sound judgment and effective decision making to drive the strategic objectives of the department and influence the broader business. In addition, the candidate is required to apply sound technical and management principles in order to drive tech transfer, process validation, process engineering and execution of support laboratory efforts and facilitate project execution and department performance within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to drive direction and have excellent communication skills in order to influence company objectives.

• Leads multi-disciplinary cross-functional projects

• Provides technical guidance to tech transfer, process validation, process engineering and laboratory efforts

• Functional management, including budget, staffing, performance management, etc.

• Oversees and maintains the MS&T strategy, procedures, business processes and tools.

• Represents the department in various technical and projects team meetings with client, regulatory and health authorities, and upper management

MINIMUM REQUIREMENTS

Knowledge, Skills, Abilities

• B.S. in Science or Engineering with minimum of 18 years industry experience, Masters with 16 years industry experience or PhD with 14 years industry experience.

• Extensive knowledge of US and EU cGMP regulations/guidance; experience with regulatory agency inspections

• Must have demonstrated biologics expertise in upstream and/or downstream processing and operations

• Must have experience in collaborating with Process Development, Quality Assurance, Supply Chain, Engineering and Manufacturing.

• Demonstrated expertise in technology transfer, process validation, process engineering and optimization/scale up of biological processes is required

• Demonstrated knowledge of industry best practices, boards of health guidelines, cGMP compliance and engineering standards is required

• Experience with cGMP production operations is required

• Experience working in a cGMP manufacturing environment is a plus

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.