DenverRecruiter Since 2001
the smart solution for Denver jobs

Senior Engineer, Manufacturing Science and Technology (Downstream)

Company: AveXis Inc.
Location: Longmont
Posted on: June 13, 2019

Job Description:

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 Senior Engineer is responsible for leading development and improvement activities for the drug product manufacturing processes used to manufacture AveXis gene therapy products at a site. This individual will be responsible for the collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.Responsibilities

  • Serve as a scientific and technical lead for drug product process-related issues and investigations at the facility.
  • Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Implement potential process improvements in conjunction with operations.
  • Participate in start-up efforts of new equipment, software or processes in manufacturing.
  • Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
  • Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
  • Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners.
  • 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 compliant manufacturing environment.
  • Assist the technical operations team to resolve any issues related to production.
  • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications
    • PhD in biochemistry, chemical engineering, bioengineering, or related technical field ORMaster of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing ORBachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing.
    • Excellent oral and written communication skills.
    • Preferred Experience:
      • 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish, additional experience in cell culture, recovery, or purification
      • Familiar with global regulations on devices, drugs, validation/qualification requirements
      • Strong technical writing ability
      • Proven ability to effectively lead and participate on teamsUp to 25% travel may be 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-RL1

Keywords: AveXis Inc., Denver , Senior Engineer, Manufacturing Science and Technology (Downstream), IT / Software / Systems , Longmont, Colorado

Click here to apply!

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

I'm looking for
in category
within


Other IT / Software / Systems Jobs


25B Information Technology Specialist
Description: 25B Information Technology Specialist Job ID: 1068779 Job Views: 42 Location: FORT COLLINS, Colorado, United States ZIP Code: 80521 Job Category: Signal and Military Intelligence Posted: 05.29.2019 Age (more...)
Company: Army National Guard
Location: Fort Collins
Posted on: 06/18/2019

MAXAR Mission Planning Services Staff Software Engineer
Description: Please review the job details below.The Staff Software Engineer will focus on Geospatial Ground System software development for the production segment of the DigitalGlobe Ground System including: core (more...)
Company: Maxar Technologies
Location: Westminster
Posted on: 06/18/2019

Software Senior Engineer #001253
Description: EMC Corporation a Dell Technologies company is seeking a Software Senior Engineer at our Louisville,
Company: EMC Corporation
Location: Louisville
Posted on: 06/18/2019


Senior .NET Developer
Description: Are you simultaneously a detective and a problem solver Do you blend technological nerdiness with the ability to evangelize it in business terms Have you been looking to hitch your wagon to an elite (more...)
Company: eBags
Location: Littleton
Posted on: 06/18/2019

Sr. Technical Support Engineer - Denver
Description: At Ping Identity, we're changing the way people think about enterprise security technology. With our innovative Identity Defined Security platform, we're helping to build a borderless world where people (more...)
Company: Ping Identity
Location: Denver
Posted on: 06/18/2019

Teach Computer Science in England
Description: Teach in England by joining a British government funded and supported teaching program called Quantum Scholars. The program operates throughout England and provides a wonderful and unique opportunity (more...)
Company: Academics LTD
Location: Greeley
Posted on: 06/18/2019

Hybris Developer
Description: Job Title : Hybris Developer Location: Denver CO Duration: 12 Months Hands on experience in all
Company: K Anand Corporation
Location: Denver
Posted on: 06/18/2019

Immidiate start caregiver
Description: We are searching for an experienced caregiver for an immediate start to join the Talem Home Care Team. If you are committed, a problem
Company: Talem Home Care
Location: Lafayette
Posted on: 06/18/2019

Software Engineer
Description: Description:. The coolest jobs on this planet--- or any other--- are with Lockheed Martin Space. At the dawn of a new space age, Lockheed Martin Space is a pioneer, partner, innovator and builder. Our (more...)
Company: Lockheed Martin
Location: Littleton
Posted on: 06/18/2019

Senior Engineer Software #2019-48447
Description: Senior Engineer-Software sought by DISH Network, LLC in Englewood, CO. 13 br Develop scalable distributed systems using Golang, Scala, JavaScript, Python support existing solutions with a variety (more...)
Company: DISH Network, LLC
Location: Englewood
Posted on: 06/18/2019

Log In or Create An Account

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

Denver RSS job feeds