This position is a key participant in the day-to-day manufacturing operations and planning of the vector production facility. Reporting to the Manufacturing Lead, the primary responsibility of the Lead Manufacturing Specialist is to lead a suite team in the manufacturing of GMP grade vectors.
S/he will participate in vector manufacturing, including support for clinical and commercial manufacturing, new product scale up, process optimization, technical transfer from process development to manufacturing, and process validation.
• Hands-on manufacture cGMP manufacture including both upstream virus production and downstream purification
• Prepares manufacturing support materials such as media and buffers
• Prepares manufacturing equipment such as packing of chromatography columns
• Performs and participates in investigations of process deviations by conducting data gathering, trending and data presentation as required
• Writes and reviews manufacturing documents and procedures such as batch records and SOPs for virus production and purification
• Maintains manufacturing equipment and records
• Maintain safety procedures and compliance records
• Contributes to manufacturing process monitoring for products transferring from research to manufacturing
• Leads efforts for troubleshooting and solving production process/equipment problems
• Organizes and manages detailed production schedules to ensure required tasks are performed
• Ensures other manufacturing specialists comply with SOPs and that training is completed
• Under the direction of Manufacturing Lead, leads the coordination and implementation of special projects such as validation or complex investigations
• Advises Manufacturing Lead on improvements which may optimize work processes
• Participates in internal meetings
• Significant knowledge of cell culture or protein purification
• Good written and verbal communication skills
• Must be adaptable
• Strict attention to detail
• Work effectively in a team environment
• Excellent organizational skills
• Ability to lead daily operations for a small four to six member team
• Ability to clearly and openly communicate with team
• Guide and develop other employees
• Requires thorough knowledge of Microsoft Office Suite
• Able to make decisions whether results obtained during the manufacturing process comply with written procedures
• Verifies process variations with more senior personnel
• Consults with higher level personnel on unexpected or out of range results
• Able to evaluate atypical events
• High degree of initiative is required in resolving problems and developing recommendations
• In collaboration with leadership, determines methods and procedures for completion of tasks
• Continual interaction with members of his/her team as well as other manufacturing suite teams
• Quality Control & Analytical Sciences
• Quality Assurance
• Service personnel
• Process Development
• Materials Management
• Must be able to lift 25 pounds
• Must be flexible with work schedule and available to work extended shift hours as determined by management
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment
• Must be able to stand for long periods of time
• Requires some contact with hazardous materials such as caustics.
• Bachelor's degree in biology, biomedical engineering, chemistry or chemical engineering required
• Generally has 5 years of relevant experience in a biopharmaceutical manufacturing facility subject to GMP regulations.
• Experience with cell culture or protein purification.
• Demonstrated deep applied knowledge and understanding of cGMP regulations.
• Strong knowledge of either upstream and/or downstream unit operations.
• Demonstrated team leadership ability.
• Strong organizational and planning skills.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.