Senior Manufacturing Associate

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Sep 07, 2018
Ref
2018-1238
Required Education
Bachelors Degree
Position Type
Full time
Overview

Are you 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.

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 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.

The Senior Manufacturing Associate is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the site. This individual will work on the manufacturing floor to operate and provide ownership for specific pieces of processing equipment. The critical responsibilities of this role 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. Other responsibilities include managing overall day-to-day manufacturing activities, supporting investigations, and working with other departments on all manufacturing to drive continuous improvements.

Responsibilities

  • 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.


Qualifications

  • Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field.
  • A minimum of 4-6 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 20% travel required
  • NOTE: This role may require the ability to travel extensively for the 1st 6-12 months of employment, including the possiblity to be assigned to other AveXis sites for a defined period of time.
  • 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.