Associate Director, Gene Therapy Manufacturing- Upstream

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Oct 17, 2018
Ref
2018-1358
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking an Associate Director, Manufacturing who responsible for organizing, managing, and continuously improving the manufacturing operations and process at the AveXis manufacturing site. This individual will be directly responsible for the teams who make up either upstream or downstream manufacturing, whose direct responsibilities include producing product on the manufacturing floor. The Associate Director of Manufacturing will provide guidance and oversite to the process and production, ensuring material is made in a safe and compliant manner and meeting company targets. The Associate Director will also be responsible for the development of staff, to accommodate AveXis' needs as a growing organization.

Responsibilities

  • Produce clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.
  • Ensure scheduled operations for manufacturing meet monthly targets. Ensure manpower resources are adequate to complete operations.
  • Lead critical level investigations as related to the manufacturing process. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
  • Ensure batch related documentation (batch records and SOPs) is closed in a timely manner to support batch release.
  • Maintain robust training program to ensure timely, efficient, and effective training of individuals.
  • Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
  • Develop and provide monthly manufacturing metrics.
  • Identify and implement continuous improvement opportunities for process and production related items.
  • Initiates various personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc.


Qualifications

  • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • A minimum of 10-12 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture and recovery.
  • Solid knowledge of FDA regulations and GMP systems.
  • Demonstrated technical knowledge of bioreactors, disposable technology, chromatography, TFF, and aseptic processing a must.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
  • A minimum of 5-8 years in a supervisory role, with increasing responsibility.
  • Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
  • Experience with viral manufacturing, and transfection a plus.


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 status.