This is a Global position and may be located in North Brunswick, New Jersey; Ingelheim, Germany; or Lyon, France. Location of the role will likely be determined by where the selected candidate is located.
The ED, Analytical Development is responsible for the leadership of global analytical development across modalities (pharmaceuticals (NCEs) and biologicals (NBEs, vaccines). The position provides strategy and leadership for all analytical development activities that contribute to the CMC development and regulatory submissions for all development projects from early development to late development and transfer to Operations (QC). This includes assay methods applicable to active ingredients/drug substances, formulations and final products, in process testing, stability testing. The role will lead the analytical development teams in all locations in Europe and the US (over 80 scientists and technical staff). A particular responsibility will be the identification and development of synergies and common technologies and approaches across modalities (pharmaceuticals and biologicals). The position will work with the research organization to provide support in the field of analytical sciences to research projects and anticipate entries into development. The position will identify and foster the introduction of innovative analytical methods t support project research and development. For biological entities the function is also responsible for Clinical Analytical Sciences (internal and CRO capabilities) The position will ensure compliance in all activities with required internal and external regulations (e.g. GxP)
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:
- Participate as an active member of the Development leadership team, helping to set and implement Development strategy.
- Ensure development and execution of analytical strategies for each development project for all modalities. Prepare and execute development steps according to plans (time, resource, quality).
- Transfer robust production processes and analytical methodologies to Operations (QC) including critical analytical reagents.
- Development of high quality CMC dossiers to support registration in collaboration with Pharma and Bioprocess teams, Technical development leaders, Formulation.
- In close collaboration with clinical, propose, develop and implement the required clinical analytical methods that are primary or secondary variables of clinical protocols. This activity will be developed with internal and external resources (CRO).
- Proactively ensure regulatory and GMP compliance in the area of GxP (especially GMP) and Work Safety.
- Responsible for ensuring the Analytical Development Functions remain aligned with external advances in science and technology and for supporting research projects, especially with the increased focus on new modalities (NBEs).
- Development of talent across the analytical development and across the organization; identification, coaching and development of key talents.
- PhD (or equivalent), from an accredited institution, in Chemical Sciences, Analytical Sciences or Pharmacy, with at least 10-20 years of relevant experience in pharmaceutical discovery or product development and management.
- At least 10-20 years of experience with pharmaceutical drug development and a strong background in analytical sciences applied to pharmaceuticals and biologicals
- Minimum of 10-15 years of experience with leadership and management of direct reports.
- Leadership of global and multi-disciplinary teams and direct reports.
- Strong interpersonal skills and communication skills.
- Strategic thinking.
- Skilled in conflict resolution and negotiation.
- Achievement focused with appropriate alignment for regulatory and quality requirements.
- Decision Making skills are critical with the ability to solve problems with speed to change
- Capability to deal with a variety of challenging matters including set-backs and failures.
- Willingness to travel internationally.
- Fluency in English is mandatory.
Desired Experience, Skills, and Abilities:
- Ability to communicate in another language such as German or French or willingness to learn the language is beneficial.
- 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.