Process Development Engineer - Upstream (Multiple Openings)
Company: AveXis Inc.
Location: San Diego
Posted on: April 18, 2019
OverviewReady to join a team committed to moving gene therapies
into the clinical and commercial settings for patients and families
devastated by rare neurological genetic diseases? AveXis is
advancing cutting-edge science to treat rare and life-threatening
genetic diseases starting with our clinical-stage, proprietary gene
therapy candidate, AVXS-101 (ZOLGENSMA--). We are in the midst of
an incredible journey and are looking for passionate individuals to
join us on this important mission.AveXis, Inc., a Novartis Company
, is a clinical-stage gene therapy company, dedicated to developing
and commercializing novel treatments for patients suffering from
rare and life-threatening neurological genetic diseases. Our
initial product candidate, AVXS-101, is our proprietary gene
therapy product candidate currently in development for the
treatment of spinal muscular atrophy, or SMA, Type 1, the leading
genetic cause of infant mortality, and for the treatment of SMA
Type 2. The U.S. Food and Drug Administration, or FDA, has granted
AVXS-101 Orphan Drug Designation for the treatment of all types of
SMA and Breakthrough Therapy Designation, as well as Fast Track
Designation for the treatment of SMA Type 1. In addition to
developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to
develop other novel treatments for rare neurological diseases,
including Rett syndrome (RTT) and a genetic form of amyotrophic
lateral sclerosis (ALS) caused by mutations in the superoxide
dismutase 1 (SOD1) gene.The Process Science Engineer I is
responsible for supporting and assisting in the design, planning
and executing experiments to develop and characterize adherent and
suspension cell culture manufacturing processes, recovery, and
downstream purification operations. These activities will support
the cGMP manufacturing operations and production of pre-clinical
and clinical material. Responsibilities
- Assist in experiments supporting the development and
implementation of a closed system, scale-up, recovery, and
purification processes for gene therapy.
- In partnership with senior PSE's, of evaluating and summarizing
data using analytical methodologies, interpreting results, drawing
conclusions and recommending options for future experiments to
achieve project goals.
- Assist in produce pre-clinical and clinical 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.
- Appropriately document experimental procedures and results
according to established guidelines. For cGMP manufacturing, ensure
documentation is being filled out correctly, training is current,
and all Quality requirements are being followed.
- 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
- Look for opportunities to implement operational excellence and
- Partner with Quality to ensure a quality and compliant
- Assist the technical operations team to resolve any issues
related to production.
- Adhere to all EH&S policies, procedures and guidelines.
- 0-2 years' experience in Biological Manufacturing
- Minimum B.S degree in biochemistry, chemical engineering,
bioengineering, or related technical field, or equivalent industry
- Excellent computer skills, proficient with Microsoft Word,
Excel, PowerPoint and Visio, and working knowledge of JMP or
equivalent statistical software.
- Excellent oral and written communication skills, written and
oral, and aptitude for problem solving.
- Preferred: 1 year 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-JH1
Keywords: AveXis Inc., San Diego , Process Development Engineer - Upstream (Multiple Openings), Engineering , San Diego, California
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