BioProcess Engineer IV - Upstream
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.
The BioProcess Engineer IV 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. May perform some supervisory duties in absence of the supervisor or in a lead role.
- 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.
- Lead 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, and complete independently.
- 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.
- Perform supervisory tasks (excluding HR related items) as required.
- 5-7 years' experience in Biological Manufacturing environment.
- 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.
The level of this position will be based on the final candidate's qualifications.
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.