Director, Bioanalytical

Job Responsibilities

• Establish processes for the CDO Bioanalytical group including RFP, timelines, communication, workflow, training program and a continuous improvement plan.
• Performs analysis as needed to meet business needs for internal and external customers for continuous growth.
• Defines teams work plans with budgets and durations for each project for internal and external customers.
• Optimizes efficiency of the working environment of the Bioanalytical group.
• Identifies new technologies and the resources required to implementation processes for continuous growth.
• Works as part of a cross functional team to services internal and external customers.
• Provides day to day mentoring to analytical scientists.
• Direct, develop, and provide technical mentoring to staff to establish operational procedures, develop technical protocols, and solve scientific problems.
• Will be responsible for setting up safety processes based on regulations for handling biologics and chemicals.
• Serves as a liaison for the Research and Development Team and Exela to external customers.

Education Requirements

Bachelor’s degree in Biochemistry or related scientific discipline with approximately 15 years industry development experience and at least 10 years’ Pharmaceutical Industry experience in a R&D and 7 years managerial experience Required. Master’s or PhD Degree Preferred.

Experience Requirements

• Must have experience working and establishing processes in CDO environment.
• Must have an excellent understanding of the theoretical background/fundamentals of Bioanalytical techniques such as PCR, DLS, HPLC, ELISA, flow cytometry, and gel electrophoresis.
• Must have experience implementing and transferring automated and high throughput analytical methods.
• Must have a strong understanding of Bioanalytical Method Validation Guidance for Industry
• Effective communicator with excellent interpersonal skills and the ability to form productive working relationships at all levels across disciplines.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance’s, Good Laboratory Practices, Good Manufacturing Practices, and ICH and USP/NF Guidelines.
• Self-motivated decision maker with a high degree of initiative, commitment and persistence to be successful.
• Sound knowledge of pharmaceutical regulatory requirements and safety practices.
• Ensure the laboratory operations meet or exceed all applicable regulatory requirements and address relevant queries from regulatory bodies.
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Experience in building a highly functional team.
• Foster a unified culture and facilitate collaboration, cooperation, transparency, accountability, and teamwork.
• Able to multitask and a strong understanding of continuous improvement.
• Good understanding and experience on hiring and employment practices.