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