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Specialist, Drug Substance Manufacturing

Company: Boehringer Ingelheim
Location: Fremont
Posted on: June 10, 2021

Job Description:

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 future.

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 department.

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

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 operational KPIs.
  • 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 responsibility.
  • Requires intermediate understanding of biopharmaceutical manufacturing and demonstrated experience with managing projects.
  • Experience with manufacturing root cause analysis, corrective/preventive actions (CAPA), performing gap assessments, lean methodology, and production planning/scheduling concepts are preferred.
  • 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 controlled documents
  • Must have excellent written and verbal communication skills.
  • 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 computer programs.
  • 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 new processes.
  • 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.

Eligibility Requirements:

Must be legally authorized to work in the United States without restriction.

Must be willing to take a drug test and post-offer physical (if required)

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 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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