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 patients!
Employee 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.
As an 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.
established regulations and follows cGMP established by
abnormalities and deviations in a timely and accurate
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.
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
- Bachelors Degree from an accredited
institution in a science or engineering related
- One (1) or more years of experience
in QC of cGMP regulated industry or equivalent
- Experience with performing
analytical methodologies relevant to Biopharmaceutical
- Experience with computer-based
systems and ideally experience.
- Technical knowledge in analytical
- Works independently with little
- Ability to concentrate on detail
oriented work in a complex technical setup with a Quality and Right
the first time mindset.
- Strong written and verbal
- Ability to read and understand SOPs
and/or methods and document work in a written format applying
- Ability to work as part of a high
performing team and collaborate effectively with
legally authorized to work in the United States without
willing to take a drug test and post-offer physical (if
Must be 18
years of age or older
At 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 growth.
Want to learn more? Visit
boehringer-ingelheim.com and join us in our effort to make more
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 law.