1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Chief Technology Officer

Job Number: 30955

Location:

Job Description

Reporting to the CEO, the Chief Technology Officer will be a key member of the Corporate Executive Team with a high degree of visibility and impact across the organization. The successful candidate will bring a strategic mindset and has a proven track record of success in leading a company’s product development, manufacturing & supply operations, including development of process control strategies and analytical development, cGMP Clinical and Commercial Manufacturing, quality management systems, risk management, and utilization of quality by design concepts for regulatory requirements. The successful candidate will define industrialization strategy for company’s medicines and embrace innovation in a fast-paced environment and has previously demonstrated the ability to build and implement internal strategy of high-quality process control, manufacturing & supply, as well as external CRO/CDMO oversight.
 
 

Responsibilities

  • Responsible for long-range strategic planning and implementation for clinical and commercial manufacturing & supply strategy for the company pipeline and management of process, manufacturing & supply teams to drive the product-specific technology and capability investment, including acquisition of pilot plant and or commercial plant if needed.
  • Build a high performing multi-disciplinary team by recruiting and developing talent and ensuring the development and implementation of appropriate training; lead and develop a strong team-based culture, fostering commitment to operational excellence and continuous improvement through transparent communication and staff engagement. Monitor Key Performance Indicators and metrics.
    • Establish a fit for purpose and phase appropriate manufacturing & supply strategic map leveraging product value inflection point, network of CDMO footprint, buy-to-own opportunity, etc.
      • Champion the company culture of quality assurance and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global health authority regulatory expectations.
      • Participate in the evolution of the company’s overall business development and partnership strategy, as an integral part of company growth strategy.
      • Manage company’s existing partnerships through well-developed quality agreement and manufacturing & supply agreement.
      • Lead the manufacturing team in operations, regulatory inspection preparedness planning and client and regulatory agency visits and inspections. Support development and implementation of CAPAs.
      • Lead CDMO selection efforts and oversee CDMO quality management system, process development, manufacturing & supply
  • Research and benchmark new technologies with the potential to increase the company’s competitive advantage

Required Skills

  • 15+ years progressive experience in a leadership/management role in biotech or pharmaceutical industries, ideally in a senior manufacturing and process development technical leadership role, preferably in development of parenteral products.
  • Knowledge of the technical and regulatory aspects of manufacturing, testing, controls, and GxPs. 
  • Experience in activities required for development of analytical techniques that support clinical and commercial manufacturing activities.
  • Prior experience in building out in-house manufacturing capability or a significant expansion or scale-up.
  • Proven ability to manage selection process, evaluate and manage manufacturing partnerships with CDMOs.
  • Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, process control strategy, process robustness, and process engineering.
  • Demonstrated track record of success in preparing and defending f submissions in clinical and market applications for FDA and foreign regulatory authorities.
  • A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
  • Motivational leadership of a cohesive high-performing team with; the ability to articulate vision and successfully drive execution.
  • Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor and the process and analytical development laboratory environment.
  • Excellent team player and be able to build and sustain organization respect and trust at all levels.
  • Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them, in all areas of CMC
  • Resilient and able to work well in a demanding, fast paced entrepreneurial environment.
  • Sound judgment and business acumen with personal versatility and flexibility as business and team evolve.

PREFERED QUALIFICATIONS:

  • Advanced degree in Medical or Life Science (Ph.D. in Biological Sciences, Chemical Engineering, Chemistry, or related discipline).

 

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