Senior Director of Technical Transfers

Position Summary

The Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This position will be the liaison between Exela and external customer with the focus of customer service. This position will be responsible for leading cross functional teams on all aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification, packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for customers. This position will lead, mentor and grow the Technical Service Department.

Job Responsibilities

Function as the customer liaison for tech transfer projects.

• Forest customer service throughout the organization and to external customers.
• Build strong relationships with customers to ensure Exela is a trustworthy partner.
• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to cross functional teams.
• Plan, direct and monitor tasks related to process development, scale-up, process optimization, customer technology transfer activities with project management assistance.
• Provide SME information on the request for pricing (RFP) process.
• Direct and coach cross functional team staff in areas such as quality, compliance, safety, project planning, process development, technology development.
• Communicate effectively with customers and executive management regarding project planning and project status, as well as project issues.
• Prepare tech transfer team goals and objectives based on compliance, scientific design requirements, project timelines and milestones.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
• Review and ensure the reliability of technical data related to formulation, process, analysis, and stability monitoring for new products and processes to be included in regulatory submissions.
• Coordinate and communicate with cross function team members throughout Exela and customers.
• Coordinate activities of the Technical Services staff with other groups within the Company to ensure the quality, timeliness and effectiveness of all activities.

Experience Requirements

• Tech transfer role focused on customer service is required.
• Theoretical and working knowledge of pharmaceutical ingredients as well as manufacturing, processing and testing equipment, along with the necessary skills to design control strategies is needed to interact with customers.
• Must have led cross functional teams and has a successful record leading these teams.
• Working understanding of pharmaceutical equipment at lab through manufacturing scale to correspond with customers.
• Ability to negotiate timelines and collaborate workload with internal and external customer to a successful outcome.
• Working understanding of statistical techniques, including experimental design.
• Working knowledge of quoting work for request for pricing (REP).
• Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
• Highly organized with strong project management skills to effectively manage multiple priorities, projects and requirements in a fast paced, dynamic environment.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• PC proficiency using Microsoft Office programs.
• Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and company policies.
• Must have experience with an emphasis on process development, scale-up, process optimization, product transfer to be the SME interacting with customers.
• Must have at least five years' experience in a managerial capacity working in a cross functional team.
• Working experience with small and large molecule in sterile injectables.

Education Requirements

• Master of Science degree in pharmacy, chemistry or related physical science preferred; or BS degree with significant, directly related experience with increasing levels of responsibility, a minimum seven years' experience in manufacturing, process