Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
The Senior BioProcess Engineer is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.
Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Provide direction on the manufacturing floor to other staff members, resolve issues, escalate when necessary and provide leadership updates.
Other responsibilities include managing overall day-to-day manufacturing activities, supporting investigations, and working with other departments on all manufacturing to drive continuous improvements.
The Senior BioProcess Engineer will be responsible for driving the process, planning ahead to avoid delays, good documentation practices, and providing leadership for the team. This individual will participate in the hiring and training of key manufacturing personnel for both upstream cell culture and downstream purification and filling operations.
• Produce clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs
• Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed
• Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Responsible for maintaining quality standards to meet cGMP requirements, CFR’s, and internal company policies related to the manufacturing process
• Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
• Provide hands on technical leadership to the manufacturing staff members
• Look for opportunities to implement operational excellence and continuous improvement
• Partner with Quality to ensure a quality and compliant manufacturing environment
• Support Director of Operations to meet information requirements as needed for quality, compliance, and management reporting.
• Assist the technical operations team to resolve any issues related to production
• Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field
• A minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with.
• Working knowledge of FDA regulations and GMP systems
• Excellent oral and written communication skills. Strong technical writing ability required
• Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence
• Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing)
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
• Approximately 10% travel required
• Must be able to routinely lift over 35 lbs.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.