Director of Solid State Science & API Engineering (SSAE), Material Analytical Science

Boehringer Ingelheim; Ridgefield (CT); Hybrid; USD 230,000 - 346,000; Full time

Job summary

Boehringer Ingelheim is seeking a Director of SSAE, MAS to provide strategic, scientific, and managerial leadership for the MAS group. The role develops and applies innovative methods and digital tools that support drug substance and drug product development, process understanding, and robust CMC decisions across global DEV NCE and DEV Biologicals.

You will mentor and grow the team, recruit top talent, collaborate with internal partners and external academia, ensure regulatory and GMP/GLP

Qualifications

• Ph.D. degree or equivalent in pharmaceutical relevant science with 10+ years of industrial or academic experience.
• Proven ability to manage, lead, and motivate others.
• Experience with DS/DP development and process understanding.
• Broad knowledge of pharmaceutical and analytical sciences.
• Experience with API crystallization and amorphous formulation development.
• Ability to collaborate with partners across functions (CMC, Operations, etc.).

Responsibilities

• Provide leadership and technical guidance across global development CMC and Operations.
• Build networks and manage interfaces with stakeholders and customers.
• Collaborate with global SMEs and leaders across disciplines.
• Develop and implement innovation strategies for MAS and BI.
• Mentor and develop talent; recruit and retain high-quality staff.
• Participate in interdisciplinary and international projects as requested.
• Ensure compliance with training, safety, regulatory, GMP/GLP, and ethics.
• Develop budgets for projects and laboratory operations.

Skills

Leadership

Strategic thinking

Communication

Negotiation

Mentoring

Team management

Education

Ph.D. in pharmaceutical science

Tools

In silico modeling

Digital tools

Job description

Description

The Director of SSAE, Material and Analytical Sciences (MAS) provides strategic, scientific and managerial leadership of the SSAE Group within the MAS Department. Material and Analytical Sciences screens, develops, and applies innovative, state-of-the art scientific methods and tools, in-silico and digital solutions, that facilitate development of drug substance, drug product and overall process understanding and robustness, thereby enabling successful development of a highly diverse and complex first-in class portfolio of NCE (New Chemical Entity) and NTM (New Therapeutical Modality) pipeline assets in Candidate Selection (CS) relevant characterization and early to late CMC development stages. A focus is on the development and application of modelling & simulation tools to accelerate and streamline development of DS and DP (predict first - confirm later). MAS works with the global Development functions (DEV NCE and DEV Biologicals), as well as Operations and Animal Health where applicable. The Director of SSAE ensures that the group meets the qualitative and quantitative goals and standards as defined by the international and local Development CMC requirements. This role develops talent through effective and agile mentorship and assignments, and continuously develops the group, including hiring of skills and competencies needed to successfully drive Boehringer’s global development portfolio.

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 Company’s success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Provides leadership and technical guidance in ensuring drug substance and drug product deliverables, and provision of expert consultation across global business units, in particular global Development CMC and Operations, , etc.
• Builds networks and actively manages key interfaces, stakeholders and customers across the development functions and beyond.
• Collaborates effectively with global SMEs & leaders across disciplines and sites.
• Develops and implements innovation strategies that enhance scientific and business value of MAS and extend its scope of influence within BI.
• Develops talent by mentoring to grow capabilities and responsibilities.
• Recruits, retains and develops high-quality staff.
• Participates in interdisciplinary and/or international Boehringer Ingelheim projects as requested by BIPI and international senior management.
• Initiating, executing, and driving initiatives for the Department or wider organization as applicable.
• Ensures compliance with all required training, safety, regulatory, HR, laboratory notebook, intellectual property, GMP´s and GLP´s (where applicable), and corporate ethics and policies.
• Ensures high visibility and influence of the department with outside organizations including academic institutions, regulatory agencies and industrial/academic associations.
• Develops budgetary requirements for projects and laboratory operations, manages and adjusts activities to operate within budgetary goals.

Requirements

• Ph.D. degree or equivalent with focus on pharmaceutical relevant science (esp. in Chemistry, Chemical Engineering) with ten plus (10+) years of industrial or academic experience, including managing groups of more than ten (10) individuals.
• Proven ability to manage, lead, and motivate others.
• Ability to propose creatively and independently, articulate, evaluate and drive innovations that bring value through improving efficiency and effectiveness in DS and DP development (such as process understanding).
• Demonstrated broad and in-depth understanding of pharmaceutical and/or analytical sciences in internal and external scientific communities.
• Extended technical experiences with API crystallization, API/ intermediate isolation, and process development, plus amorphous formulation development.
• Extensive knowledge on NCE/ NTM DS and DP development in various stages from pre-candidate selection till launch.
• Proven track record of driving innovations and applying cutting-edge scientific principles in development of robust, efficient processes and formulations, analytical methods, in silico and digital tools and technologies/concepts that expand capabilities beyond the current state.
• Demonstrated ability to collaborate with, negotiate and influence business partners in CMC Development and other business functions (Operations, etc.).
• Demonstrated ability to lead/ drive and participate in interdisciplinary and/or international teams.
• Effective communication, coaching, and negotiating skills.
• Existing alliances with academia and relevant external scientific bodies.
• Demonstrated ability to prepare technical reports, publications and oral presentations both to scientists (internally and externally) and senior level management.
• Ability to manage all aspects of group operations and critical components of departmental operations.
• Understanding of, and compliance with, all applicable regulations and BI business procedures.

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.

Compensation Data

The base salary range for this position is $230,400 to $345,600. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here (https://www.boehringer-ingelheim.com/us/careers/explore-our-company/our-total-rewards) .

JOB ID

37061

Job function

Development

Career level

Leadership

Organization

BI Pharmaceuticals, Inc.

Working time

Full-Time

Job flexibility

Hybrid

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law