Principal Scientist, Analytical Science
US-BI Fremont
 Fremont, CA

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!

Description:

Regularly leads several process science teams or is an SME in one functional area. Regularly acts as the process science representative on several project teams. May manage a small group of scientists and perhaps a senior scientist. Frequently solves complex problems with some precedent. Occasionally solves unprecedented complex scientific problems based on experience and fundamental scientific knowledge. Has discretion in day to day and week to week operation of groups or teams, in alignment with functional area's and projects long term objectives. Serves as an SME to regulatory agencies, BI VPs and customers.

The primary responsibility of this position is to provide leadership and direction (to/within) the Analytical Science group in Process Science for development and technology transfer of analyticals and/or formulations in support of process development, toxicology, clinical and/or commercial manufacturing. This position will deliver results through effective management of a team of scientists, and build and maintain effective cross-functional partnerships with stakeholders such as Manufacturing and Quality.

This position will direct, coach and mentor managers and/or staff members. Also responsible for developing and administering resources, schedules and goals and support translation of business plans into objectives.

This position will ensure development support, technology transfer and development of analytical methodologies, and oversee clinical supply planning and execution.

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:

  • Develop standards around which lab staff members operate, and is accountable for administration and results in his/her functional areas.
  • Responsible for applying state of the art technologies to enable reliable clinical supplies that are consistent in quality and are manufactured according to cGMP, including continuous assessment of new development, analytical and manufacturing technologies to reduce development timelines and to increase productivity and product quality to ensure competitive position.
  • Responsible for generating innovative, business driven ideas to improve processes and technologies for the corresponding functional areas including writing proposals, supporting, and/or managing external collaborations.
  • Responsible for the development of analytical methods for therapeutic biologics by applying state of the art technologies for analyzing bulk product.
  • Responsible for assisting in acquisition and efficient transfer of analytical methods from third parties and if required, implementation of method adaptations.
  • (For the formulation function): Lead and drive the development of formulations.
  • Responsible for leading the development and optimization of and scientific troubleshooting for analytical methodologies required to ensure, high quality and safe product to support pre-clinical and clinical studies and commercial manufacturing.
  • Responsible for planning and executing xperiments in support of analytical method qualification and product characterization.
  • Responsible for effective development of biopharmaceuticals by driving decisions with internal and international partners as well as with regulatory agencies.
  • Ensure development & transfer of analytical methods for therapeutic biologics to manufacturing or QC, including CMO and NBE/Biosimilar projects.
  • (For the formulation function): This position is responsible for the development of formulations for therapeutic biologics by applying state of the art technologies.
  • Builds, develops and maintains a lab with cutting edge expertise and capabilities.
  • Mentors, coaches and develops staff and supports capability and skill level improvement.
  • Provides effective management of the Analytical Science group within a project matrix concept. Manages interfaces, maintains flexibility, and prioritizes workload in order to complete complex and variable projects tasks.
  • Permanent development of a technically & scientifically oriented team to ensure personal development, increase flexibility and improve processes.
  • Collaborates closely with other Lab Heads, Principle Scientists, Senior Scientists and partners.
  • Fosters a flexible true team culture (One PS team) and support others as needed to allow organization to rapidly adapt to the dynamic business environment and changing project portfolios.
  • Develops climate and working atmosphere that encourages scientists and employees to seek constant improvement and implement Business Process Excellence.
  • Possession of management and leadership competencies to develop a group of highly motivated and strong scientists is mandatory.
  • Possession of excellent leadership skills and the ability to motivate and develop employees is essential. Furthermore, strategic thinking, business orientation, communication and negotiation skills, interpersonal sensitivity and fast decision making are very important for the daily business.
  • Identify and establish state-of-the-art technologies for analysis (including asset management and strategic investments).
  • Foster an innovative environment/culture in alignment with the line management and Director of BioProcess Engineering.
  • Ensure continuous improvement and technology leadership and build a stronger IP position for BI.
  • Keep up to date with external patents and literature; pursue active presentation/publishing and patenting strategies.
  • Present technology and scientific results at international symposia / congresses.
  • Represent Analytical Science in the different decision bodies and meetings for NBE, Biosimilar and CMB.
  • Ensure development & transfer of analytical methods for therapeutic biologics to manufacturing or QC, including CMO and NBE/Biosimilar projects.
  • Ensure timely supply of analytical methodologies required to ensure, high quality and safe product to support pre-clinical and clinical studies and commercial manufacturing (including CMO and NBE/Biosimilar projects).
  • Additional competencies related to intercultural interaction (e.g. Europe and Asia) to successfully cooperate with global partners are necessary.
  • Beyond the technical expert knowledge and leadership competencies, understanding of the global Biopharma Business is helpful.
  • Understanding key tasks in research and development enables communication at the interfaces.
  • Strategic thinking to systematically develop the organization.
  • Knowledge of SixSigma and LEAN are helpful.
  • Compliance with regulatory authorities, e.g. virus clearance, method qualification, assistance with regulatory dossiers and GMP requirements, safety at work (EHS) and customer relations/visits (internal/clients).
  • Ensure worker safety including training, supervision and control of safety guidelines.
  • Understand current regulatory guidelines for production of human recombinant products, including process or method validation.

Requirements:

  • Doctoral degree in Biochemistry plus two (2) plus years’ experience and/or Masters’ degree in Biopharmaceuticals and nine (9) to twelve (12) years’ experience and/or Bachelors’ degree in Chemistry plus ten (10) to twelve (12) years’ experience.
  • Two (2) to four (4) years’ experience leading employees, projects and leaders is required.
  • 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
  • Analytical techniques (e.g., HPLC, CE, ELISA, bioassay, Mass Spectrometry)
  • Understanding of formulation development for biotherapeutics

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 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.

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