Director of Solid State Science & API Engineering (SSAE), Material Analytical Science (Ridgefield, CT, United States, Connecticut)

Biopharma Careers; Ridgefield (CT); On-site; USD 230,000 - 346,000; Full time

Job summary

Boehringer Ingelheim’s MAS division seeks a Director of SSAE to lead drug substance/product development and analytics. You will guide strategic scientific directions, mentor teams, and ensure compliance with regulatory and BI policies across global projects.

The role emphasizes building partnerships, accelerating DS/DP development through advanced modelling, and driving innovations that expand capabilities within BI’s global portfolio.

Qualifications

• Ph.D. in pharmaceutical science with 10+ years leading groups.
• Proven ability to manage, lead, and motivate others.
• Ability to propose and drive innovations to improve DS/DP development efficiency.
• Broad, in-depth knowledge of pharmaceutical/analytical sciences.
• Experience with API crystallization, isolation, process development, and amorphous formulation.
• Extensive knowledge of NCE/NTM DS/DP development from pre-candidate to launch.
• Track record in driving innovations across robust processes, analytics, in silico and digital tools.
• Ability to collaborate and influence partners in CMC and Operations.
• Lead and participate in interdisciplinary/international teams.
• Effective communication, coaching, negotiation.
• Alliances with academia and external bodies.
• Prepare technical reports and presentations for scientists and management.
• Manage group operations and departmental activities.
• Understanding regulatory compliance and BI procedures.

Responsibilities

• Provides leadership and technical guidance across global development CMC and Operations.
• Builds networks and interfaces with stakeholders across development functions.
• Collaborates with global SMEs and leaders across disciplines and sites.
• Develops and implements innovation strategies to extend MAS influence.
• Mentors and develops staff; recruits and retains high-quality personnel.
• Participates in Boehringer Ingelheim projects as requested by management.
• Initiates and drives department-wide initiatives.
• Ensures training, safety, regulatory, and ethics compliance.
• Maintains visibility with outside organizations including academia and regulators.
• Develops budget requirements for projects and operations within budget.

Skills

Leadership

Innovation

Communication

Collaboration

Education

Ph.D. in pharmaceutical science

Job 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

This position offers a base salary typically between $230,400.00 and $345,600.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits.