Director, Validation - Equipment and Facilities

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Aug 28, 2019
Ref
2019-4106
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

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 Director of Validation is responsible for defining the equipment and facility validation strategy, validation program and leading the execution, both routine and project, used to manufacture AveXis gene therapy products. Working with Quality, Quality Control, Engineering and Manufacturing, this individual will collaborate to build a lead the development of validation protocols and reports, aseptic process qualification, shipping validation and cleaning validation approach for the commercial and clinical products across the manufacturing network. In addition, this individual will be the technical validation lead for process technical transfers across the manufacturing network.

Responsibilities

  • Member of the Global Engineering & Facilities (GEF) leadership team with responsibility as site representative for all GEF functions to the Site Leadership Team.
  • Lead and develop a team of CQV engineers for routine and project validation concurrently.
  • Work closely with other departments to define the company's validation philosophy / strategy and to ensure the Validation Program is effective and efficient including linkages and compliance of SOPs and other procedures related to validation activities. Oversees the development and execution of CQV strategies, policies, and procedures compliant with the above philosophies, policies and programs.
  • Ensure that projects are executed, and all deliverables are generated in accordance with policies and practices.
  • Work with multi-disciplinary engineering/capital project teams, ensuring in-scope project objectives are met on-time and on-budget. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
  • Responsible for oversight of equipment qualification activities in support of product manufacturing for both clinical and commercial manufacturing.
  • Partner with IT Validation on computer system validation oversight.
  • Maintenance of Master Validation Plan for the sites and that the Validation Program is in compliance with regulatory requirements.
  • Create and maintain the department budget.
  • Prioritizing and scheduling of activities and managing resources.


Qualifications

  • B.S. degree in science or engineering or related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing.
  • Excellent oral and written communication skills.
  • 12+ years of experience in senior validation roles within a biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
  • Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.


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.

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