Specialist, Manufacturing Site Metrics

Location
Durham, NC, US
Posted
Sep 02, 2020
Ref
5388
Hotbed
Bio NC
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? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

The Specialist, Manufacturing Site Metrics, is responsible to support each of the functional areas in the primary and secondary manufacturing processes including: engineering, validation, MSAT, maintenance, QC and QA groups at the site.

Responsibilities
  • Establishes key metrics, tracking results, and supports the sites ability to perform and deliver to plan.
  • Ensures our programs and manufacturing are in a state of control.
  • Establishes cross-functional alignment on sitewide metrics.
  • Implements visual control boards and provides ongoing support to each of the sitewide functions.
  • Establishes Key Performance Indicators for each of the functions such as on-time delivery, on-time closure or various records, schedule adherence etc.
  • Identifies, develops and implements robust process improvements through lean principals.
  • Supports the Project Management Office group for any technology transfer activities
  • Supports site change controls.
  • Maintains quality standards to meet GMP requirements, CFR's and internal company policies with respect to operations.
  • Other related duties as assigned.

Qualifications
  • B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools.
  • In-depth knowledge of FDA regulations and GMP systems and experience interacting with various regulatory agencies in a highly regulated or pharmaceutical / biotech facility.
  • Applied knowledge of quality by design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
  • Excellent oral and written communication skills. Strong technical writing ability.
  • Travel to other sites, vendors, and CMOs (~10%).


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.

Novartis Gene Therapies 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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