Vice President of Manufacturing
2 weeks ago
Job Description: Vice President of Manufacturing and Engineering
Job Title: Vice President of Manufacturing and Engineering
Job Level: Reporting to the CEO, Transpire Bio
Location: Weston, Florida, USA.
Summary
Reporting to the Chief Executive Officer, the VP of Manufacturing and Engineering will be in charge of operations of Transpire Bio manufacturing facilities. As a senior member of the management team, they will participate in setting the company’s strategic direction and formulating both long and short-range objectives, policies, programs and best practices. They are a key driver of fostering an operational excellence culture at all levels of the organization. The VP of Manufacturing and Engineering is a hands-on position that oversees management of all areas of manufacturing from R&D to commercial production.
Essential Duties and Responsibilities
Facility Construction
the construction and development of Transpire Bio manufacturing facility including sterile manufacturing plant
and implement construction strategies aligned with company goals and objectives
all aspects of TBI’s construction projects, ensuring compliance with quality, regulatory and statutory requirements, cost control, and efficiency, always observing lean, modular construction concepts
New Product Introduction
with R&D, Commercial, QA, Project Management, Regulatory Affairs to ensure smooth launch of new products
R&D for manufacturing of exhibit batches on time by providing adequate resources whenever required
strategies to make new products cost competitive through value engineering
appropriate skillsets are developed to launch new products while ensuring that the products reach the market on time and ensure process robustness of new products before launching
partners with internal teams and external partners for successful technology transfer and validation of new or existing processes/products
Manufacturing Leadership
the formulation of manufacturing strategies and enable the achievement of manufacturing objectives
technical and administrative leadership to all manufacturing sites
strategic planning for the direction and control of manufacturing, product development and technical support activities
long-term objectives and standards of performance for the department, and assure that it achieves objectives and project completion within budget and time frame
plans and procedures for maintaining high standards of manufacturing operations, ensuring products conform to established quality standards
for planning, sourcing, production and delivery to ensure product quality, cost and delivery requirements are met
and maintain relationships across the company with all levels of internal and/or external parties including but not limited to clinical, global planning, marketing, manufacturing, regulatory, customers and other key stakeholders
Compliance and Quality
culture of compliance as the foremost objective across manufacturing sites and employees including adherence to cGMP, EH&S and all relevant regulatory and statutory requirements
updated and understand the future direction of all regulatory agencies through participation in global forums and proactively shape compliance strategies and plans
a safe and health-oriented work environment for all
a culture where customer service and quality are at the heart of everyday business
Operational Excellence
latest technology trends, by assimilating opinion of vendors/ partners, in equipment, processes and utilities to ensure that remains current and future-ready on cost/quality/productivity
and support Operational and Cost Excellence Programs to generate/nurture ideas and deliver measurable business impact while aligning to revenue budgets, manpower productivity
and support Manufacturing Excellence initiatives to ensure that continuous improvement projects are being undertaken on an ongoing basis
life-cycle management of the manufacturing facilities including optimization and upgrade of technology and equipment.
continuous process improvement, reduction of rejects, efficiency of production lines, reduction of manufacturing costs, use of key performance indicators and benchmarking
demonstrate operational excellence and the balance of calculated risk taking
Team Development and People Management
organization and culture building initiatives across manufacturing operations and support cascade of values/ desired behaviors for manufacturing
recruitment of the right talent and develop them through structured coaching initiatives
performance management, reward and recognition and career planning decisions for manufacturing
and guide focused training, knowledge management initiatives and exposure to best practices
mentor, advise, and share industry best practices with team members, peers and senior management
a culture of collaboration, growth, and innovation within the production and construction teams
Qualification Requirements
or higher degree in Manufacturing Engineering, or Production Engineering or equivalent with 15+ years of pharmaceutical industry experience or a Doctoral degree with 10+ years of experience and 5+ years of managing people. Minimum 5+ years of Aseptic Manufacturing experience. Must have depth and breadth of knowledge within all aspects of Aseptic Manufacturing
in leading the Manufacture of sterile Drug Product is a must
knowledge of sterile product manufacturing; successfully launched sterile products for the US Market
understanding of commercial pharmaceutical manufacturing environments and quality systems
to interact effectively with internal and external personnel; strong team leader (including leading cross-functional teams); ability to function effectively at the C-suite level
verbal and written communication skills (including technical writing and editing skills) are essential. Must possess good oral and written English language skills.
knowledge of surrounding areas including Regulatory Affairs, Quality Assurance, Clinical Affairs and Medical Affairs
knowledge of the USP, cGMP, various FDA, EMA, ICH, and ISO guidelines for Industry, along with knowledge of the regulatory process pertaining to drug development, registration, review and approval.
to handle day-to-day functions while still providing high-level strategic guidance
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