Boehringer IngelheimFremont is the rapidly growing US arm of Boehringer Ingelheim’s BiologicsBusiness Unit. We are a fully integrated biologics operation with over 500scientist and specialists, covering cutting edge early- to late stage CMCdevelopment, clinical and commercial drug substance and drug productmanufacturing, medical device assembly for combination products and packagingoperations.
We are continuing ourrapid growth, investing over $200m into the expansion of our capacity andcapabilities, and creating approximately 200 new jobs.
Driving this growth isan exciting pipeline of multiple Boehringer Ingelheim novel biologic entities(NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeuticswe develop and manufacture for other leading pharma and biotech companies. Thisincludes multiple commercial product launches planned over the next coupleof years, for which we can tap into Boehringer Ingelheim’s uniqueexperience of having brought 30+ biologics to market globally.
Leveraging our diversetalent pool, we are also driving technology and innovation globally, throughmajor investment and collaborations into next generation manufacturingplatforms and technologies, which may change how biologics will be made in thefuture.
Whether we work on ourown products, help partners to bring their products to market or innovate newtechnologies and approaches - Everything we do, we do to helppatients! #LI-MS1 *I-SF1
Regularly leads several process science teams or is the SME on two or moreprocess science functional areas. Regularly acts as the process sciencerepresentative on several project team. Manages a large group ofscientists, engineers, senior scientists, senior engineers, engineers andmanagers Frequently solves unprecedented complex scientific problems based onexperience and fundamental scientific and engineering knowledge. Hassignificant discretion in day to day and week to week operation of groups orteams, in alignment with Process Science's long term objectives Serves as aProcess Science spokesperson to the FDA or other regulatory agencies, to VPs inBI, and to high level customers.
This position will beresponsible for leading a Process Science development lab, which includesdeveloping scaleable processes, transferring processes into GMP manufacturing,and acting as a principal investigator for multiple projects. This positionwill manage a highly technical team of scientists and interfaces with bothinternal and external customers. This position will develop andadminister budgets, schedules, and goals and translate business plans from theDirector, Process Science to objectives for job functions in the lab supportingupstream activities, tech transfer and scale up. This position will beaccountable to drive technical innovation into upstream processes and be aprimary interface with BI Contract Manufacturing Business clients.
As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery, developmentand delivery of our products to our patients and customers. Our global presenceprovides opportunity for all employees to collaborate internationally, offeringvisibility and opportunity to directly contribute to the companies' success. Werealize that our strength and competitive advantage lie with our people. Wesupport our employees in a number of ways to foster a healthy workingenvironment, meaningful work, diversity and inclusion, mobility, networking andwork-life balance. Our competitive compensation and benefit programs reflectBoehringer Ingelheim's high regard for our employees.
- Develop scalable processes (such as mammalian cell culture and harvest processes, purification processes)
- Lead technology development programs in one Process Science lab (cell culture, protein science) in alignment with budget. Propose new technologies for further development.
- Provide leadership and management to a group of scientists and engineers. Ensure worker safety including training, supervision and control of safety guidelines.
- Identify, propose, and execute process and procedural changes to improve process performance, robustness, productivity and efficiency.
- Keep up to date with external patent and literature environment; pursue active presentation/publishing and patenting strategies.
- Collaborate within department and cross-functionally to meet set objectives.
- Facilitate/lead technology transfers from CMO customers and participate in the customer interface as required. Organize scientific presentations for internal discussion and as needed to inform both internal and external customers.
Associate Director Requirements:
- Doctoral degree and/or Masters’ degree and or Bachelors’ degree with eleven plus (11+) years’ experience with a focus in Biochemistry, Biopharmaceuticals or Biology.
- Four (4) to six (6) years’ experience leading employees and projects.
- At least ten plus (10+) years of MS industry experience, thorough knowledge of biotechnology process development methodologies.
- Thorough knowledge of GMP biotechnology manufacturing.
- Previous experience in successfully managing scientific and engineering function
- Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality
- Ability to lead effectively in a matrixed organization
- Excellent communication and management skills
- Understanding of validation of biopharmaceutical facilities, equipment and process
Sr. AD Requirements:
- Degree from an accredited institution in Biochemical Engineering, Bioengineering, Chemical Engineering, or any related field.
- Doctoral degree with six-plus (6+) years, and/or Master's degree with twelve-plus (12+) years, and/or Bachelor's degree with thirteen-plus (13+) years of relevant industry experience.
- Six-plus (6+) years’ experience leading employees, project and leaders.
- Proven track record in developing manufacturable upstream process for mammalian cell culture, with thorough knowledge of biotechnology process development methodologies.
- Thorough knowledge of GMP biotechnology manufacturing.
- Thorough knowledge in CMC Development for biologics manufacturing.
- Understanding of validation of biopharmaceutical facilities, equipment and process.
- Excellent communication and management skills.
- Proven skills building and maintaining productive relationships with organizational partners such as manufacturing, quality, and similar functions across the company network.
- Strong ability to influence in a team environment and collaborate with peers.
- Proven track record of building and leading small to large teams of highly qualified scientists and engineers.
- Strong team leadership and staff coaching and development skills.
- Ability to lead effectively in a matrix organization.
- Maintain a continuous process improvement mind set and in depth understanding of transformations/change management.
- Translate innovation goals into scientifically sound projects.
- Support and implement Process Science mission, vision and strategy and as representative at all interfaces.
- Understanding of current regulatory guidelines for production of biological products, including process validation.
Must be legallyauthorized to work in the United States without restriction.
Must be willing to takea drug test and post-offer physical (if required)
Must be 18 years of ageor older
Who We Are:
At Boehringer Ingelheimwe create value through innovation with one clear goal: to improve the lives ofpatients. We develop breakthrough therapies and innovative healthcare solutionsin areas of unmet medical need for both humans and animals. As a family ownedcompany we focus on long term performance. We are powered by 50.000 employeesglobally who nurture a diverse, collaborative and inclusiveculture. Learning and development for all employees is key because yourgrowth is our growth.
Want to learnmore? Visit boehringer-ingelheim.com and join us in oureffort to make more health.
Boehringer Ingelheim,including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal HealthPuerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equalopportunity and affirmative action employer committed to a culturally diverseworkforce. All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; national origin;age; ancestry; citizenship status, marital, domestic partnership or civil unionstatus; gender, gender identity or expression; affectional or sexualorientation; pregnancy, childbirth or related medical condition; physical orpsychiatric disability; veteran or military status; domestic violence victimstatus; genetic information (including the refusal to submit to genetictesting) or any other characteristic protected by applicable federal, state orlocal law.