Manager, Quality Control Biochemistry
Company: AveXis Inc.
Posted on: March 28, 2020
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. 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 the world's
leading gene therapy company, redefining the possibilities for
patients and families affected by life-threatening genetic diseases
through our innovative gene therapy platform. Founded in 2013 and
headquartered in Bannockburn, IL, the goal of AveXis' cutting-edge
science is to address the underlying, genetic root cause of
diseases. AveXis pioneered foundational research, establishing AAV9
as an ideal vector for gene transfer in diseases affecting the
central nervous system, laying the groundwork to build a
best-in-class, transformational gene therapy pipeline. AveXis
received its first U.S. Food and Drug Administration approval in
May 2019 for the treatment of spinal muscular atrophy (SMA). AveXis
is also developing therapies for other genetic diseases, including
Rett syndrome and a genetic form of amyotrophic lateral sclerosis
(ALS) SOD1. Be a part of a team reimagining the treatment of rare
and devastating genetic diseases with transformational gene
therapies.The Manager, Quality Control Biochemistry will own all
work processes associated with the Biochemistry laboratory
including overseeing testing activities and ensuring compliance
with respect to methods, protocols and procedures. This position
will be the subject matter expert for Biochemistry related
activities during regulatory inspections and the document owner for
procedures in support of the Quality Control Programs.
Responsibilities include, but are not limited to program
management, technical writing, training, metrics, and
investigations. The Manager, Quality Control Biochemistry must have
a strong understanding of analytical techniques, manufacturing
operations, GMPs and the principles behind them and be an effective
communicator with the ability to lead investigations and
identify/implement CAPAs. Responsibilities
- Develops organizational structure and fosters talent
management, including performance and succession planning,
interviewing and training to support the company's business
- Develops functional capabilities within the department to keep
pace with advances in technology and company growth.
- Creates a safe and dynamic work environment that supports an
innovative, efficient and flexible organization.
- Fosters a culture of compliance and excellence in quality
throughout the company.
- Develops departmental expertise in testing and documentation
that will meet legal and regulatory requirements for products.
- Develops cooperative and strong working relationships with
Manufacturing, Quality Assurance and MS&T to achieve company
- Develops and coordinates the Quality Control laboratory
activities and capabilities to provide timely, accurate and cGMP
compliant testing of raw materials, in-process materials, bulk and
contract manufactured materials.
- Guides the activities of the Quality Control group to ensure
that the company has robust product stability programs for domestic
and international products.
- Oversees the approval of all specifications, procedures and
formulas that impact the strength, quality, purity, and efficacy of
manufactured and contract-manufactured products.
- Ensures proper investigation into the root cause of product
and/or process failures, and assists in determining appropriate
product disposition and/or process improvements.
- Ensures that internal and external laboratories comply with GMP
- Collaborates with MS&T and/or outside contract labs to
ensure seamless method validation and transfer.
- Participates in business sub-teams as a subject matter expert
to provide input on timeliness and to address
analytical/microbiological related issues.
- Designs and implements laboratories at manufacturing
- Accountable for Method Development, Qualification and
- Ensures routine testing and generation of Certificate of
- Bachelor's Degree in Chemistry, Biology or related
- Minimum 8 years of relevant experience in GMP testing
laboratory with 4 years of supervisory experience.
- Strong understanding of cGMP regulations.
- Understanding of analytical techniques such as ELISA, HPLC,
Electrophoresis, Spectrometry, Physical Chemistry, etc.
- Deep experience with methods d validation and transfer.
- Ability to work effectively within the site and across 3 rd
party testing laboratories.
- Ability to work independently and effectively, prioritize and
deliver on tight timelines.
- Outstanding problem-solving abilities.
- Demonstrated ability to lead in a collaborative environment
with a positive leadership style and a hands-on approach that
emphasizes team work, collaboration, influencing, motivating, and
consensus and team building.
- Good critical thinking, deductive reasoning, and
decision-making skills.Approximately 10% travel 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-GK1
Keywords: AveXis Inc., Durham , Manager, Quality Control Biochemistry, Executive , Durham, North Carolina
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