03 Aug
Specialist, Manufacturing Site Metrics
North Carolina, Durham 00000 Durham USA

Vacancy expired!

OverviewReady 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 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.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.#LI-JB1Need help finding the right job?We can recommend jobs specifically for you!Job Locations US-NC-DurhamPosted Date 3 hours ago (8/3/2020 4:07 PM)Job ID 2020-5388# of Openings 1Category Manufacturing

Vacancy expired!


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