Senior Project Manager
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.
AveXis is seeking a Senior Project Manager for our San Diego office to represent the AveXis-San Diego site, working closely with the local functional teams including analytical development (AD), quality control (QC) and Process Science departments to support local analytical development and CMC activities associated with AveXis' pipeline programs. The individual will also partner with global PMs across AveXis sites and other key stakeholders to ensure timely and successful IND and BLA filings and to help manage program advancement from preclinical to clinical and to commercial stages. This role will be responsible for developing, forecasting, maintaining, and reporting timelines for analytical development and CMC activities in a fast-paced environment.
- Provides leadership of the IND-enabling Manufacturing and Supply Chain activities by driving analytical and QC deliverables to meet successful IND submission timelines and subsequent advancement of the clinical programs.
- Directs multi-functional teams to achieve desired business objectives and timelines.
- Facilitates high level workflow via program forecasting, and is responsible for developing, maintaining, tracking and reporting timelines.
- Works closely with SMEs in AD to support method development, optimization, qualification, co-validation, tech transfer and/or other analytical activities, leveraging CMC Project Management Experience.
- Interfaces with Process Science, Analytical, QC, and Sample Management leadership, other functional leaders, and corresponding PMs to guarantee aligned strategies and timelines.
- Point person for partner CROs and CMOs, maintains vendor relationships, and manages vendor RFPs, proposals, contracts, and purchase orders.
- Organize/lead meetings, manage project meeting content and track project objectives and progress.
- Ensures that POs and invoices are maintained, and monitors QC and analytical budgets.
- Reports on project progress, identifying issues/risks and offering risk mitigation and viable solutions as they arise.
- Determines and manages project scope and engages SME support as needed to ensure alignment is in place for all QC team projects.
- Escalates project risks to the leadership team of SMEs, stakeholders and decision makers.
- Motivates the team and creates a positive and collaborative environment that results in timely delivery of goals and overall team success.
- Minimum B.A. or B.S. in a scientific discipline with preference of M.S. or Ph.D. degree majoring in biochemistry and chemistry or related science field.
- Minimum of 10 years of experience working in a GMP QC or analytical development laboratory environment, with experience in QC method and tech transfer required.
- Understanding in the biologics manufacturing workflow is preferred but not required.
- Proven ability to manage multiple high-level tasks effectively - must have strong MS project, excel, and PowerPoint skills.
- Experience in supporting IND filing and/or advancing drug programs from pre-clinical to clinical stages while interacting with diverse departments is highly desired.
- The ideal candidate is enthusiastic and engaging; excellent communication and interpersonal skills are must.
- PMP Project Management certification preferred, but not required.
- Desire and ability to work in a fast-paced, dynamic environment.
- Approximately 10% travel required.
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