Senior Manager, Quality Control - Biochemistry

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Sep 28, 2019
Ref
2019-4256
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 Senior Manager, Quality Control (QC) Biochemistry will own all work processes associated with the Biochemistry laboratory including overseeing testing activities and ensuring compliance with respect to methods, protocols and procedures. This position will represent Biochemistry during regulatory inspections and will be the document owner for procedures in support of the Quality Control Programs. Responsibilities include, but are not limited to program management, technical writing, training, metrics, and investigations.

The incumbent must have a strong understanding of analytical techniques, manufacturing operations, GMPs and the principles behind them. He/she must be an effective communicator with the ability to lead investigations and identify/implement CAPAs.

Responsibilities

  • Manage the QC Biochemistry laboratory for AVXS platform products, working closely with Manufacturing and contract laboratory organizations.
  • Lead the validation and transfer of analytical methods to support the AveXis pre-clinical and clinical material programs.
  • Support the establishment of reference standards and controls to support AVXS platform products.
  • Provide analytical documentation to the FDA and international regulatory agencies during regulatory submissions.
  • Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
  • Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
  • Recruit, develop and mentor staff and provide support to ensure successful accomplishment of business goals.
  • Develop cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives.
  • Oversee the approval of specifications, procedures and formulas that impact the strength, quality, purity, and efficacy of AveXis and contract manufactured products.
  • Ensure proper investigation into the root cause of product and/or process failures and assist in determining appropriate product disposition and/or process improvements.
  • Ensure that internal and external laboratories comply with GMP standards.
  • Participate in business sub-teams as a subject matter expert to provide input on timeliness and to address analytical/microbiological related issues.
  • Ensure generation of Certificate of Analysis.
  • Perform analytical trending.
  • Perform other related duties as assigned.


Qualifications

  • Bachelor's Degree in Chemistry, Biology or related sciences.
  • Minimum 10 years of relevant experience in a GMP testing laboratory.
  • 5 years of prior management experience preferred.
  • Strong working knowledge of protein chemistry and analytical test methodologies: Immunoassays, PCR, chromatography, and electrophoresis.
  • Prior experience with method development and validation of biologics, QC, stability, IND submissions, BLA or NDA submissions is important for success in the position.
  • Strong understanding of applicable USP, ICH, and Ph Eur regulations as they relate to QC testing.
  • Expertise in use of Excel or comparable software solutions for management and analysis of data.
  • Ability to work effectively within the site and across third party testing laboratories.
  • Ability to work independently and effectively, prioritize and deliver on tight timelines.
  • Outstanding problem-solving abilities.
  • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building.
  • Good critical thinking, deductive reasoning, and decision-making skills.
  • Approximately 10-15% 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.

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