DurhamRecruiter Since 2001
the smart solution for Durham jobs

Director, Global Sterility Assurance

Company: AveXis Inc.
Location: Durham
Posted on: November 11, 2019

Job Description:

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 Sterility Assurance serves as the key functional expert for the Global Aseptic processing function in the AveXis network. This person will be responsible for providing the technical leadership, direction and management of the sterility assurance quality operations to support viral gene therapy products. This includes development/optimization of current processes and programs to ensure compliance with regulatory requirements, implementation of Annex 1, organization development, and making appropriate decisions and recommendations to address trends, issues or significant observations related to sterility assurance. The Sterility Assurance Director also acts as the owner of the global quality sterility assurance initiatives, working with senior stakeholders such as the site operations and quality heads, Novartis representatives and AveXis senior quality leaders to ensure global sterility assurance support is provided. Responsibilities The Director Sterility Assurance provides technical leadership for sterility process assurance and microbial control for viral gene therapy products as required to assure compliance with cGMP and regulatory requirements. Provide expert advice and appropriate technical support to ensure site readiness for regulatory and internal inspections by supporting sites in their preparation. Lead and support investigations for microbial contamination events and help establish root cause and CAPA. Direct AveXis team in the justification of microbial controls and limits for viral gene therapy products. Drive implementation of new technologies related to microbial monitoring and controls. Primary for optimization and uniformization of aseptic techniques, cleaning and disinfection programs, microbiological monitoring and sterilization techniques between sites within the network. Provides technical expertise for marketed and clinical products and can represent the company in discussions with regulatory agencies. Also provides support for regulatory audits and filings. The scope of activities for the teams includes interactions with R&D, Operations, Quality, Commercial and regulatory as well as the relevant technical plant support functions both within AveXis and at third party manufacturers. Lead cross site/platform and network projects such as the Annex 1 implementation. Qualifications Minimum B.S. degree in scientific or technical field preferably in Microbiology. Master's Degree and/or PhD is preferred. A minimum of 8-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities. Experience with viral gene therapies and/or orphan disease indications is a plus. Deep understanding of microbiology and aseptic processes. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Excellent verbal, written communication skills and the ability to interface with multiple areas within the organization is essential. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward for microbial contamination events. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. The global nature of the job requires the position to have excellent knowledge of the various regulatory and GMP requirements as well as outstanding communication skills. Approximately 25% 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. #LI-GK1

Keywords: AveXis Inc., Durham , Director, Global Sterility Assurance, Other , Durham, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Travel Nurse - OR RN - Operating Room Registered Nurse
Description: Travel Surgery Nurses NeededCirculators Scrub NursesNebraska Travel RN Nursing AssignmentsGeneral, Cardiovascular Outpatient Surgery experience--The Travel Nurse Season is here and it shows--One quick (more...)
Company: HealthCare Travelers (Nursing)
Location: Wilson
Posted on: 11/14/2019

Call Center Position Available
Description: GET TO KNOW ALORICA br br At Alorica, we only do one thing - make lives better, one interaction at a time. We're a global leader in customer service and experience, serving the world's biggest brands (more...)
Company: Alorica
Location: Rocky Mount
Posted on: 11/14/2019

25U Signal Support Systems Specialist
Description: Job Description Communication is the pulse of Army National Guard units, and it's up to the Signal Support Systems Specialist to ensure the information keeps flowing so the military doesn't miss a beat. (more...)
Company: National Guard
Location: Danville
Posted on: 11/14/2019


Member Support
Description: Position Summary...What you'll do...Maintains safety of facility according to company policies and procedures by conducting safety sweeps following procedures for handling merchandise and correcting (more...)
Company: Sam's Club
Location: Danville
Posted on: 11/14/2019

Bid On Local HVAC Jobs - Reach New Customers In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Wilson
Posted on: 11/14/2019

42A Human Resources Specialist - Danville
Description: Job Description When a Soldier has a question about benefits, policy, or needs help with a sensitive issue, the Army National Guard's Human Resources Specialist is the primary go-to person. As an HR Specialist, (more...)
Company: National Guard
Location: Danville
Posted on: 11/14/2019

CDL-A Company Drivers
Description: Tanker Driver Benefits br br Full-Time Drivers Average 62k- 67k per year, and high-achievers earn 75k br Home nightly/daily for petroleum:
Company: Eagle Transport
Location: Danville
Posted on: 11/14/2019

CDL Truck Driver: Earn An Extra $12,000 Your First Year - $1000 Paid Every Month!
Description: CDL Truck Driver: Earn An Extra 12,000 Your First Year - 1000 Paid Every Month Don't Wait, Call Now 423-445-7250 LIMITED TIME U.S. Xpress is now offering an EXTRA 12,000 IN YOUR FIRST YEAR (more...)
Company: U.S. Xpress
Location: Wilson
Posted on: 11/14/2019

Class A CDL Delivery Driver - Sign on Bonus!
Description: Professional CDL-A Delivery Driver br br br Twice the Opportunities br br We have two distribution centers in Rocky Mount - br br each with great, but different delivery opportunities. (more...)
Company: McLane Company
Location: Wilson
Posted on: 11/14/2019

Travel Speech Language Pathologist - $1,820 per week
Description: NurseFly Travel Nursing with Synergy Medical Staffing is seeking a travel speech language pathologist for a travel job in Wilson, North Carolina: br - Specialty: Speech Language Pathologist br - Discipline: (more...)
Company: TherapyFly Travel Therapy
Location: Wilson
Posted on: 11/14/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds