DenverRecruiter Since 2001
the smart solution for Denver jobs

BioProcess Engineer II (Upstream)

Company: AveXis Inc.
Location: Longmont
Posted on: July 13, 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 BioProcess Engineer II 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. 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. #LI-RL1

Keywords: AveXis Inc., Denver , BioProcess Engineer II (Upstream), Engineering , Longmont, Colorado

Click here to apply!

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

I'm looking for
in category
within


Other Engineering Jobs


Sr Operations Engineer in Development
Description: Join our team and experience Workday br br It's fun to work in a company where people truly believe in what they're doing. At Workday, we're committed to bringing passion and customer focus to the (more...)
Company: Workday
Location: Boulder
Posted on: 07/18/2019

AWS Security Engineer
Description: Title: AWS Security EngineerLocation: Denver, COType: Contract U.S. Citizens, Green Card Holders, and those authorized to work in the U.S. for any employer will be considered.Summary: ul li AWS, (more...)
Company: Ascent
Location: Denver
Posted on: 07/18/2019

Mechanic
Description: POSITION OVERVIEW The Service Technician performs vehicle repair and maintenance as assigned in accordance with dealer and factory standards and builds Customer loyalty by developing trust and ensuring (more...)
Company: AutoNation Ford Littleton - Autonation
Location: Littleton
Posted on: 07/18/2019


Senior Cloud Engineer
Description: Recurly has an immediate opening for the Senior Cloud Engineer who will be responsible for building and maintaining the Cloud infrastructure on which all of Recurly's IT systems and services are built. (more...)
Company: Recurly
Location: Boulder
Posted on: 07/18/2019

Endpoint Cybersecurity Engineer - Grimlock with Security Clearance
Description: Secure our Nation, Ignite your Future Entering ManTech's 50th year, we hold the distinct honor of being named a Top 100 Global Technology Company by Thomson Reuters. We understand that in order to hold (more...)
Company: Mantech International Corporation
Location: Denver
Posted on: 07/18/2019

Mechanic
Description: Position Overview br The Service Technician performs vehicle repair and maintenance as assigned in accordance with dealer and factory standards and builds Customer loyalty by developing trust and ensuring (more...)
Company: AutoNation Ford Littleton - Autonation
Location: Littleton
Posted on: 07/18/2019

Civil Design Engineer
Description: Civil Design Engineer br br LocationLoveland, ColoradoDivision br br Engineering br br DescriptionJoin the TAIT Team We are looking for talented, motivated, and technically driven individuals (more...)
Company: TAIT & Associates
Location: Loveland
Posted on: 07/18/2019

Principal Structural Engineer
Description: Principal Structural Engineer SNC is currently seeking exceptional candidates who wish to be a part of the commercial space revolution. Our fun, fast-paced and collaborative team designs, builds, and (more...)
Company: Sierra Nevada Corporation
Location: Louisville
Posted on: 07/18/2019

Principal Structural Engineer
Description: SNC is currently seeking exceptional candidates who wish to be a part of the commercial space revolution. Our fun, fast-paced and collaborative team designs, builds, and flies the Dream Chaser Cargo System, (more...)
Company: Sierra Nevada Corporation
Location: Louisville
Posted on: 07/18/2019

Senior Security Engineer - DDoS Specialist
Description: DDoS Sr. Security Engineer New opening with a Global Telecommunications Company who is looking to add a Sr. Security Engineer to lead automation, innovation and research trends/trends to the security
Company: eFinancial Careers
Location: Lafayette
Posted on: 07/18/2019

Log In or Create An Account

Get the latest Colorado jobs by following @recnetCO on Twitter!

Denver RSS job feeds