KBI Biopharma Inc.
Senior Vice President, Site Head
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
Senior Vice President, Site Head
Apply locations USA - NC - Durham - National Way
Time Type: Full time
Posted on: Posted 3 Days Ago
Job Requisition ID: R00006677
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.
Responsibilities:
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.
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.
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.
Ensure 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.
Extensive biotechnology experience working within senior operational management. Broad experience within the industry (i.e. Operations, Development, Quality and Regulatory) and demonstrated outstanding leadership and ambition.
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 complex documents. Ability to respond effectively to sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style.
Reasoning Ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Math Ability:
Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
Computer Skills:
Word processing, spreadsheets, PowerPoint, 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 workforce. 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.
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Time Type: Full time
Posted on: Posted 3 Days Ago
Job Requisition ID: R00006677
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.
Responsibilities:
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.
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.
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.
Ensure 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.
Extensive biotechnology experience working within senior operational management. Broad experience within the industry (i.e. Operations, Development, Quality and Regulatory) and demonstrated outstanding leadership and ambition.
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 complex documents. Ability to respond effectively to sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style.
Reasoning Ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Math Ability:
Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
Computer Skills:
Word processing, spreadsheets, PowerPoint, 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 workforce. 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.
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