The role holder will have full oversight for all major activities at the site, receiving reports from all the site’s directors and senior directors. This role will have overall responsibility including adherence to schedule, quality and cost objectives to ensure effective execution of client programs while maintaining profitability of the site and highest ethical and compliance standards. The role reports directly into the Chief Operating Officer.
The role holder directly leads manufacturing operations while also coordinating all site functions at the commercial cell culture site in North Carolina. He/She also leads the operations readiness activities in order to enable successful start-up of the facility.
Build and manage a cross functional CDMO site encompassing all site functions. Inherent to the role is formulating and implementing the strategic plan that guides the activities required to enable a successful start-up of the facility and profitable commercial operations.
Coordinate efforts with department leaders and liaison with the customer on delivery. Interface with all department leaders to ensure they are enabled to be successful.
Cross functional management skill set including finance, operations, quality and program management. Team builder with the ability to inspire and develop talent. Overseeing the complete operation of the site in accordance with the direction established in the strategic plans. Planning, staffing, guiding, leading and managing the site in order to accomplish the site’s responsibilities and deliverables. Roll out of the corporate BSC and related metrics.
Develop profitable site budgets and revenue targets in order to achieve corporate financial and strategic goals. Responsible for directing the site performance in order to achieve those targets.
Achieving the organization’s overall strategic goals, revenue growth objectives, and profitability requirements as determined by the strategic plans.
Maintain a strong grasp of customer service concept, with the ability to read and react to customer needs.
Focus on quality improvement for the organization. Identify efficiency opportunities and implement Opex initiatives to implement lean operations. Managing the overall business plan.
Directly manage manufacturing operation staff involved in producing drug substance in the facility including Upstream Manufacturing and Downstream Manufacturing.
Manage the establishment of procedures for maintaining high standards of manufacturing operations to ensure compliance with safety regulations as well as customer and corporate quality standards. Actively participate in corporate sustainability and corporate culture initiatives. Lead staff hiring, oversee training and execution. Develop an engaged and high-performing team. Provide clear direction and balanced performance feedback; coach, develop, and challenge direct reports; Take corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations.
REQUIREMENTS:
- Senior level manager with a proven track record of complex program management and cross disciplinary organizational management. A minimum of 15 years of experience in a small, mid-size and larger corporate environment (preferred). Demonstrated success of effectively leading change and organizational growth through strategic planning. Solid and effective oral and written communication skills. Personal qualities include the ability to inspire and motivate.
- Ideal candidates will have extensive biotechnology experience working within senior operational management. The candidate must have broad experience within the industry (i.e. Operations, Development, Quality and Regulatory) and demonstrated outstanding leadership and ambition. The incumbent should come from a strong project background, having had experience managing multiple projects including both technical and financial oversight.
- Must have good working knowledge of financial and accounting principles and finance techniques including budgeting and revenue forecasting.
- BS, MS or Ph.D in a relevant scientific/engineering discipline (e.g. chemical engineering, biochemistry, biology, etc.) with 15 or more years of industrial experience in the field of pharmaceutical/biotechnology. Considerable experience in all aspects of biological API development (operations, plant design, process development and engineering, validation, process control, and quality assurance. Thorough knowledge of biotech manufacturing techniques obtained in a cGMP facility. Demonstrated people management and organizational development experience along with multimillion-dollar capital management experience preferred.
- Language Ability: Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or board of directors.
- Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
- Math Ability: Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Computer Skills Word processing, Spreadsheets, Power Point, E-mail
The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
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.
