Sr. Associate, QC Analytical Tech
Company: BIOMARIN
Location: Novato
Posted on: May 18, 2023
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Job Description:
Sr. Associate, QC Analytical Tech Location Novato, California
Workstyle Open to Hybrid Apply Who We Are
For more than two decades, going our own way has led to countless
breakthroughs, bettering the lives of those suffering from rare
genetic disease. In 1997 we were founded to make a big difference
in small patient populations. Now we seek to make an even greater
impact by applying the same science-driven, patient-forward
approach that propelled our last 25 years of drug development to
larger genetic disorders, as well as genetic subsets of more common
conditions. Through our unparalleled expertise in genetics and
molecular biology, we will continue to develop targeted therapies
that address the root cause of the conditions we seek to treat.
Applying our knowledge to make a transformative impact is not just
a calling, but an obligation to those who will benefit most. The
end goal has always been better lives and now we can reach
more.
And the more people we reach, the more our impact can grow. We
transform lives through genetic discovery.
Our Culture
Our desire to make a positive impact on our patients extends to our
employees and BioMarin is committed to fostering an inclusive
environment where every person feels seen, valued, and heard - so
employees can thrive in all areas of their lives, in and outside of
work. We seek to provide an open, flexible, and friendly work
environment to empower people and to provide them with the ability
to develop their long-term careers. Ultimately, we want to be an
organization where people enjoy coming to work and take pride in
our efforts to help patients.
BioMarin's Technical Operations group is responsible for creating
our drugs for use in clinical trials and for scaling production of
those drugs for the commercial market. These engineers,
technicians, scientists and support staff build and maintain
BioMarin's cutting-edge manufacturing processes and sites, provide
quality assurance and quality control to ensure we meet regulatory
standards, and procure the needed goods and services to support
manufacturing and coordinating the worldwide movement of our drugs
to patients. Come join our team and make a meaningful impact on
patients' lives.
Role The QC Analytical Technology (QCAT) Senior Associate will
collaborate with internal and external stakeholders to support
BioMarin's clinical development and commercial manufacturing
testing activities. Key activities include supporting the
development of control system strategies for new and existing
products; supporting in-country test laboratories, supporting the
method lifecycle management, oversight of compliance of methods and
specifications to Health Authority, Industry and Pharmacopeia
guidelines and requirements, providing analytical technical support
to QCAT operations and site QC operations teams when required,
preparing validation and transfer master plans for analytical
methods, authoring regulatory submission documents and regulatory
responses. Ownership and management of project plans for QCAT
activities, being a key subject matter expert for regulatory
inspections. Training and educational development of other staff
members are also expected. This position reports to the QCAT
Analytical CMC Lead. Education and Experience Required
PLEASE NOTE: Absent a Medical or Religious reason that prohibits
vaccinations, all our incoming employees must be vaccinated for
COVID-19.
We are an equal opportunity employer and all qualified applicants
will receive consideration for employment without regard to race,
color, religion, gender, gender identity, sexual orientation,
national origin, disability status, protected veteran status, or
any other characteristic protected by law.
In the U.S., the salary range for this position is $ 91,200 to $
136,800 per year, which factors in various geographic regions. The
base pay actually offered will take into account internal equity
and also may vary depending on the candidate's geographic region,
job-related knowledge, skills, and experience among other factors.
A discretionary bonus and/or long-term incentive units may be
provided as part of the compensation package, in addition to the
full range of medical, financial, and/or other benefits, dependent
on the level and position offered. Apply Be the first to receive
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Keywords: BIOMARIN, Novato , Sr. Associate, QC Analytical Tech, Other , Novato, California
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