DurhamRecruiter Since 2001
the smart solution for Durham jobs

BioProcess Engineer II - Buffer/Media Prep

Company: AveXis Inc.
Location: Durham
Posted on: January 17, 2020

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 BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. ***This role requires the ablity to work 12-hour shifts within our 24x7 operating enviornement. Shifts may include weekends and/or nights.*** Responsibilities

  • Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
  • Support the product requirements to ensure that all products are produced according to plan.
  • Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
  • Participate in information requests for FDA and internal audits of the manufacturing facilities.
  • Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process.
  • Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
  • Look for opportunities to implement operational excellence and continuous improvement.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Assist the technical operations team to resolve any issues related to production. Qualifications
    • 2-4 years' experience in Biological Manufacturing environment.
    • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
    • Excellent oral and written communication skills.
    • Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. 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. #L1-TT1

Keywords: AveXis Inc., Durham , BioProcess Engineer II - Buffer/Media Prep, Engineering , Durham, North Carolina

Click here to apply!

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

I'm looking for
in category

Other Engineering Jobs

Sr. DevOps Engineer
Description: Senior DevOps Engineer Do you have what it takes to manage complicated, global, open-source infrastructure Potential candidates will join a highly-skilled team, and will need to be familiar with emerging (more...)
Company: Vaco Technology
Location: Raleigh
Posted on: 01/29/2020

Job Engineer
Description: Job Description The job engineer assists and acts as a liaison between contractors, superintendents, foreman, estimators, and engineers for a specific
Company: The Lane Construction Corporation
Location: Raleigh
Posted on: 01/29/2020

Senior DevOps Engineer - Raleigh/Durham
Description: Senior DevOps Engineer - Raleigh 125-175,000 We are working with a leader in the healthcare industry that are in a period of expansion and seeking to expand the global DevOps Team with the addition of (more...)
Company: Reperio Human Capital Inc.
Location: Raleigh
Posted on: 01/29/2020

Data Engineer
Description: Hi ALL, Greetings from SRS Consulting Inc. Please find the below job description and let me know if you
Company: SRS Consulting Inc
Location: Raleigh
Posted on: 01/29/2020

Big Data Engineer
Description: Big Data Engineer - Boston - Base Salary Bonus Relocation assistance In this role you will be the full time employee of my client while working on a long term project for a large financial institution (more...)
Company: Jefferson Frank
Location: Raleigh
Posted on: 01/29/2020

FPGA Hardware Design Engineer
Description: FPGA HARDWARE DESIGN ENGINEER - Raleigh, NC. Direct hire / W2 opportunity with benefits, relocation, sponsorship if needed and the opportunity to live in Raleigh, NC where the
Company: TES - The Employment Solution
Location: Raleigh
Posted on: 01/29/2020

Facilities Project Engineer- Manufacturing Operations
Description: The Facilities Project Engineer will be responsible for executing the major elements of Cellectis US manufacturing operations strategy and provides lifecycle project management expertise to the site. (more...)
Company: Cellectis
Location: Raleigh
Posted on: 01/29/2020

Smart Workspace Staff Engineer
Description: Job ID : 80164 br br Location: USA-NC-Raleigh br br Functional Area: Information Technology br br Facility: Corporate Office br br Relocation Provided: No br br Education (more...)
Company: Lenovo
Location: Raleigh
Posted on: 01/29/2020

Electrical Design Engineer
Description: A Electrical Design Engineer job is currently available through Belcan in Raleigh, NC. This job is a F.T. position. You will be responsible for performing technical work along with coordinating, communicating, (more...)
Company: Belcan
Location: Raleigh
Posted on: 01/29/2020

Windows 10 Engineer
Description: Experience rolling out Windows 10 Experience building PC's/Laptops Experience with MS Surface Pro laptops. Setting up of user hardware,
Company: eclaro
Location: Raleigh
Posted on: 01/29/2020

Log In or Create An Account

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

Durham RSS job feeds