Director, Laboratory Technical Research & Development in
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Director, Laboratory Technical Research & Development Job Locations
US-CO-Longmont Posted Date 5 days ago (9/9/2020 3:40 PM) Job ID
2020-5435 # of Openings 1 Category Research and Development
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
The Director, Laboratory Technical Research & Development, is
responsible for leading the laboratory operations in support of
process design, experimental design and execution, scale model
development and management, investigational testing for cGMP
operations support, operational and capital budgeting, laboratory
strategic trajectory planning, project planning and execution,
laboratory operational systems development and therapeutic product
program development support in addition to defining and directing
the activity of scientific and engineering staff.
Responsibilities Executes and documents experimental procedures
in support of process development activities supporting
investigational, clinical and commercial gene therapy programs
including but not limited to new process design and development,
process proof of concept through characterization studies in
alignment with program strategy, pre-clinical materials generation
and documentation, direct clinical and commercial GMP operations
support, scale-up studies, raw materials evaluation as well as
process optimization and improvement studies ,
Supports laboratory operations process development activities in
drug substance (upstream, intermediate and downstream), drug
product (formulation, filling, packaging and labeling) and critical
raw materials, media and buffer manufacturing.
Builds and maintains a high performing staff of managers,
engineers and scientists to support process and platform
Serves as a key scientific and technical representative for
process-related issues pertaining to new products as well as
licensed products manufactured at internal AveXis sites, as well as
with external partners.
Develops, implements and maintains process development
laboratory operations systems that support safe, efficient and
compliant work processes, continuous improvement, data integrity
and operational excellence.
Partners with multiple manufacturing organizations to understand
operability requirements and potential process improvements for
existing and new processes and incorporate those requirements into
process design studies.
Prioritizes and drives a continuously changing portfolio of lab
studies within a laboratory network and according to business need
while communicating and managing competing priorities leveraging
organizational management practices such as personnel loading
assessments, capacity evaluations, capital and space planning and
organizational design evaluations.
Oversees the development of experimental procedures that
interrogate, define and document Normal Operating Ranges (NORs),
Proven Acceptable Ranges (PARs), facility fit assessments, scale-up
demonstrations for biopharmaceutical products in upstream,
downstream and/or fill finish areas.
Delivers direct support of pre-clinical, clinical and commercial
manufacturing operations through investigational testing of
in-process pools, raw material assessments, impurity clearance,
adventitious agent clearance and process capability
Leverages experimental planning and design practices such as
design of experiment (DOE), risk assessment and edge of failure
determination to accelerate process development activities.
Directs support of Pre-Clinical Study material generation
including readiness studies prior to manufacture of new molecules
on platform processes and phase appropriate documentation
development and delivery.
Leads and manages the establishment, documentation and
maintenance of scale models.
Builds a robust data packages that directly support regulatory
submissions for new and approved gene therapy biopharmaceutical
Reviews and provides feedback and technical/scientific support
on project deliverables, i.e. remediation initiatives, plan
Other related job duties as assigned.
Qualifications B.S. degree in biochemistry, chemical
engineering, bioengineering, or related technical field, Master’s
degree or PhD preferred.
10 years of experience in biopharmaceutical based process
development and/or cGMP manufacturing operations including direct
experience in cell culture, recovery, purification and/or aseptic
fill/finish, direct viral production & purification experience
7 years leadership experience.
Familiar with global regulations and regulatory submission
requirements (CMC) pertaining to Gene Therapy development and
Excellent communication skills and attention to details.
Excellent oral and written communication skills.
Strong organizational skills and ability to multi task across
projects and activities.
Proven ability to effectively lead and participate on teams.
Approximately 10% to 30% travel.
The level of this position will be based on the final
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
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