Boehringer Ingelheim Fremont is the
rapidly growing US arm of Boehringer Ingelheim’s Biologics Business
Unit. We are a fully integrated biologics operation with over 500
scientist and specialists, covering cutting edge early- to late
stage CMC development, clinical and commercial drug substance and
drug product manufacturing, medical device assembly for combination
products and packaging operations.
We are continuing our rapid
growth, investing over $200m into the expansion of our
capacity and capabilities, and creating approximately 200 new
Driving this growth is an exciting
pipeline of multiple Boehringer Ingelheim novel biologic entities
(NBEs) and biosimilars, as well as, a growing diverse portfolio of
therapeutics we develop and manufacture for other leading pharma
and biotech companies. This includes multiple commercial product
launches planned over the next couple of years, for which we
can tap into Boehringer Ingelheim’s unique experience of having
brought 30+ biologics to market
Leveraging our diverse talent pool,
we are also driving technology and innovation globally, through
major investment and collaborations into next generation
manufacturing platforms and technologies, which may change how
biologics will be made in the
Whether we work on our own products,
help partners to bring their products to market or innovate new
technologies and approaches - Everything we do, we do to help
assigned to QC functional or technical area in either HPLC/CE,
Potency testing (Bioassay and Binding assays), Residual Impurities,
Physicochemical/Drug Product, Microbiology/Environmental
monitoring, Raw Materials/Cleaning validation/verification and
Packaging testing. Executes routine analytical testing of bulk drug
substance and drug product in a multi-product facility.
Executes Raw Material sampling and testing and sampling of clean
rooms (as applicable). Proficiency in 1-3 analytical
methodologies. Performs technical and quality review of data.
Responsible for routine maintenance, quality and compliance
activities. Performs duties under supervision and according
to standard operating and QC procedures.
employee of Boehringer Ingelheim, you will actively contribute to
the discovery, development and delivery of our products to our
patients and customers. Our global presence provides opportunity
for all employees to collaborate internationally, offering
visibility and opportunity to directly contribute to the companies'
success. We realize that our strength and competitive advantage lie
with our people. We support our employees in a number of ways to
foster a healthy working environment, meaningful work, diversity
and inclusion, mobility, networking and work-life balance. Our
competitive compensation and benefit programs reflect Boehringer
Ingelheim's high regard for our employees.
independently with adequate training 1-3 analytical tests
methods with oversight by qualified staff.
Coordinates and performs
with oversight by qualified staff fundamental tasks such as but not
prep, TCU maintenance, and cleaning. Performs routine
compliance activities of low complexity including test record
verification, log book checks, archiving, etc.
work according to cGMP and cGDP.
to established regulations and follows cGMP established by
abnormalities and deviations in a timely and accurate
to safety standards and identifies unsafe situations / habits and
own training within compliance and may train other technicians and
associates on operations upon completion of trainer
issues to Sr Staff and line management.
data and Identifies discrepancies.
with Sr staff to assess them and appropriate root causes are put in
Work in a
highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow
all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS
Degree from an accredited institution in a science or engineering
or more years of experience in cGMP regulated
QC Experience preferred.
performing analytical methodologies relevant to Biopharmaceutical
to concentrate on detail oriented work in a complex technical setup
with a Quality and Right the first time mindset.
written and verbal communication skills.
computer-based systems and ideally experience with process control
experience to read and understand SOPs and/or methods and document
work in a written format applying cGMP/GDP standards.
to work as part of a high performing team and collaborate
effectively with staff.
knowledge in analytical methods.
independently with little supervision.
legally authorized to work in the United States without
willing to take a drug test and post-offer physical (if
18 years of age or older
Who We Are\:
Boehringer Ingelheim we create value through innovation with one
clear goal\: to improve the lives of patients. We develop
breakthrough therapies and innovative healthcare solutions in areas
of unmet medical need for both humans and animals. As a family
owned company we focus on long term performance. We are
powered by 50.000 employees globally who nurture a diverse,
collaborative and inclusive culture. Learning and development
for all employees is key because your growth is our
learn more? Visit boehringer-ingelheim.com and join us in our
effort to make more health.
Boehringer Ingelheim is
an equal opportunity global employer who takes pride in maintaining
a diverse and inclusive culture. We embrace diversity of
perspectives and strive for an inclusive environment, which
benefits our employees, patients and communities. All qualified
applicants will receive consideration for employment without regard
to a person’s actual or perceived race, including natural
hairstyles, hair texture and protective hairstyles; color; creed;
religion; national origin; age; ancestry; citizenship status,
marital status; gender, gender identity or expression; sexual
orientation, mental, physical or intellectual disability, veteran
status; pregnancy, childbirth or related medical condition; genetic
information (including the refusal to submit to genetic testing) or
any other class or characteristic protected by applicable