Director, Process Development *PC 419

Your Tasks: 

This position is responsible for overseeing the development of robust and efficient processes for the scaleable production purification, and characterization of disease specific Lentiviral vectors capable of supporting clinical therapies

Essential Duties and Responsibilities:

• Lead efforts to identify, develop or optimize methods necessary to ensure therapeutic products are of a high quality and can be manufactured in a cost effective and reproducible manner
• Responsible for performance of duties and delivery within the Process Development, pre-Clinical Production, and Analytical Method Development teams
• Evaluate the potential and practicality of processes in development in order to plan appropriate actions to accomplish company goals
• Develop and implement methods and procedures for monitoring projects such as preparation of records of expenditures, research findings, and reports in order to inform senior management of current status of projects related to organizational goals
• Support the transfer of methods from research to clinical processing, interfacing with both manufacturing and research teams to improve and scale up new and existing products.
• Design, optimize and characterize processes for the manufacture of therapeutic products.
• Responsible for the Technology Transfer of production processes to GMP manufacturing and Analytical methods to Quality control, interfacing with manufacturing, quality, and research teams to improve and scale up new and existing products and methods.
• Scale-up and further development of upstream and downstream production processes, including yield optimization, cost of goods reduction, media optimization, and improvement of regulatory compliance.
• Develop methods for commercial supply of Lentiviral vectors, including the supply of vector for pre-clinical use to demonstrate feasibility
• Work with Quality and Manufacturing teams on building a commercial process that aligns with a Quality-by-Desgn (QbD), risk-based approach including appropriate controls, assays, and validation.
• Oversee the development and implementation of a process monitoring and control strategy program using appropriate statistical guidelines
• Maintain accurate records of experimental results, analysis and interpretation of experimental data.
• Manage department budget.
• Present information, in group settings, to management, business partners, other employees, as well as prepare technical reports.
• Supervise the activities and progress of process development personnel for timely delivery of the group’s defined goals and objectives.
• Develop SOPs and other GMP documentation.
• Participate in Corrective and Preventive Action (CAPA) activities.

Requirements: 

• Masters in Life Sciences; 5 to 8 years of related experience in Process Development; or equivalent combination of education and experience.
• 10 years’ experience in GMP biologicals production facility and at least 7 years of management / supervisory experience.
• Experience with Mammalian cell culture and production of viral vaccines or viral vectors.

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscope