Specialist, Drug Substance Manufacturing
Company: Boehringer Ingelheim
Posted on: June 10, 2021
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 jobs.
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 globally.
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!
To manage and/or own continuous improvement initiatives, global
BI projects, BIFI site initiatives, and BIOS projects within the
manufacturing department. Additionally this role will be
responsible for managing production readiness activities for the
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
Duties & Responsibilities:
- Actively participate in the identification and implementation
of manufacturing procedure improvements intended to optimize
existing processes and ensure achievement of regulatory and safety
requirements. Update GMP documentation as required.
- Ensure work environment meets Boehringer Ingelheim and industry
standards. Initiate lean manufacturing techniques in order to
actively reduce process and change over cycle times.
- Identifies areas for Continuous Process Improvement and apply
operational excellence tools to reduce process variability and
steadily deliver measurable efficiency gains.
- Report findings to management team and team members with
recommendations for improvement. Research new methods or steps in a
process, present findings, and make recommendations to the team,
including developing new and revised Standard Operating Procedures,
implementing new equipment and/or developing new processes.
- Prepare reports and/or presentations to maintain/track
- Manages and supports pre-production readiness for assigned
product(s), including but not limited to: batch documentation
authoring, revision, and oversight, manufacturing point of contact
for qualification & validation activities, equipment and parts
availability, execution of change control actions, and implementing
improvements to the pre-production readiness program. Supports
investigations and corrective/preventive actions (CAPA) during and
after batch execution, as required.
- Applies project management skills and concepts to lead or
manage projects with an interdisciplinary project team, and from
planning stage to project completion.
- Bachelor's degree from an accredited institution, preferably in
a science or engineering related field, plus two (2) years'
experience in a cGMP pharmaceutical manufacturing environment with
positions of progressive responsibility.
- Associate's degree from an accredited institution, preferably
in a science or engineering related field, plus five (5) years of
manufacturing experience in a cGMP pharmaceutical manufacturing
environment with positions of progressive responsibility.
- High School Diploma with seven (7) years of cGMP pharmaceutical
manufacturing experience in positions of progressive
- Requires intermediate understanding of biopharmaceutical
manufacturing and demonstrated experience with managing
- Experience with manufacturing root cause analysis,
corrective/preventive actions (CAPA), performing gap assessments,
lean methodology, and production planning/scheduling concepts are
- Excellent oral communication skills
- Must exercise rapid learning ability, attention to detail,
excellent computer skills, team player, organized analytical
thinker with a high level of energy and self-motivation.
- Ability to read, develop and understand procedures and other
- Must have excellent written and verbal communication
- Must have well-developed interpersonal skills with the ability
to establish highly functional relationships with diverse
personalities both within and outside the manufacturing.
- Demonstrated proficiency in MS Office programs and associated
- Must be able to work in a team environment.
- Strong working knowledge of biopharmaceutical manufacturing
practices, as well as an intermediate understanding of biologics
principles, is required. Requires strong interpersonal skills to
manage projects across multiple teams.
- Has limited experience in managing projects. Possesses
knowledge of cGMP systems.
- Experience participating in the identification and
implementation of manufacturing procedure improvements intended to
optimize existing processes.
- Experience in initiating lean manufacturing techniques.
- Ability to research new methods or steps in Pharmaceutical
manufacturing processes. Experience presenting making
recommendations and experience developing new and revised Standard
Operating Procedures, implementing new equipment and/or developing
- Ensures compliance with all manufacturing processes in
accordance with Government (cGMP, FDA, DEA, OSHA, and Safety) and
Company Policies, Procedures, Goals and Objectives. Demonstrates
good knowledge of GMP, FDA and European regulations. Follow all
relevant department policies, procedures, SOP and other
requirements during project execution and act at all times within
the BI standards/ethics policies.
Must be legally authorized to work in the United States without
Must be willing to take a drug test and post-offer physical (if
Must be 18 years of age or older
Who We Are:
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 health.
Boehringer Ingelheim, including Boehringer Ingelheim
Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer
Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal
Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an
equal opportunity and affirmative action employer committed to a
culturally diverse workforce. All qualified applicants will receive
consideration for employment without regard to race; color; creed;
religion; national origin; age; ancestry; citizenship status,
marital, domestic partnership or civil union status; gender, gender
identity or expression; affectional or sexual orientation;
pregnancy, childbirth or related medical condition; physical or
psychiatric disability; veteran or military status; domestic
violence victim status; genetic information (including the refusal
to submit to genetic testing) or any other characteristic protected
by applicable federal, state or local law.
Keywords: Boehringer Ingelheim, Fremont , Specialist, Drug Substance Manufacturing, Other , Fremont, California
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