Principal Scientist , Material and Analytical Sciences

This position is located within the drug substance-drug product interface organization in Ridgefield, CT, working to advance the development of novel active compounds within Boehringer Ingelheim’s small molecule pipeline. A thorough knowledge of drug development processes and applications of chemical engineering and process chemistry principles throughout the phases of drug process development is required. Specifically, this position, in close collaboration with colleagues in CMC Development groups and Operations, will develop phase-appropriate isolation processes for robust and efficient delivery of APIs that meet desired quality attributes such as purity, crystal form and material properties. The successful candidate is expected to identify process improvements, conduct risk assessment, devise novel solutions and strategies to complex process challenges and implement in the manufacturing settings. The individual will additionally be responsible for solid form screening and advanced solid state characterization techniques of small molecules, while authoring and supporting documents for regulatory authorities and IP. Areas of focus include polymorph, salt, co-crystal screenings and identification, solid form assessment and selection. Other key areas include scalable crystallization processes, solid form control, impurity rejection and design of targeted material attributes for drug product. The individual is expected to integrate QbD principals, guide experimental design with a focus of process understanding and robustness, thermodynamic principles and phase behavior, participate in cross-functional teams, prepare technical reports, develop and apply new technologies for solution crystallization to enable integrated API/DP development approach.

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Leads in designing and implementing experimental studies and concepts to develop isolation processes to deliver target solid form, chemical purity and other identified critical quality attributes.
• Implements scale-up strategies for drug substance with a focus of process understanding, identification of critical process parameters and process optimization.
• Collaborates effectively with CMC partners to transfer isolation processes and assess performance, robustness and scalability.
• Proactively works with chemistry partners locally and globally to resolve scale-up issues relating to crystallization, material properties and solid state chemistry. Conduct risk-assessments and develops transferable mitigation solutions.
• Designs and implements appropriate solid form screens in response to project demands. Distills solid form understanding into understandable and actionable communication for interface partners.
• Resolves solid form relationships based on thermodynamic principles in utilization for process development and execution and DP applications.
• Responsible for technical reports and quality in a timely manner.
• Function as an acknowledged resource and technical leader within and outside Material and Analytical Sciences (MAS) in a specific project relevant area or technology; demonstrates appropriate scientific and regulatory knowledge. Provide guidance and expertise to advance R&D projects or evaluates and proposes new technologies and concepts, in support of multiple R&D projects.
• Demonstrates broad knowledge in field of expertise. Keeps abreast of relevant literature and its interpretation; develops visibility outside of functional area.
• Complies with all applicable regulations. Ensures that work performed in area of responsibilities conducted in a safe and compliant manner. Manage all aspects of laboratory operations.

Requirements

• Ph.D. Degree or equivalent in Chemical Engineering, physical chemistry, organic chemistry or related fields with five plus (5 ) years related experience in a related field
• Relevant experience and knowledge in a specialized area or preferably a range of scientific areas and/or techniques.
• At least 4 years post-graduation of pharmaceutical industry or relevant industrial experience in chemical engineering, process chemistry, physical chemistry or related fields.
• One (1) to three (3) years project management/leadership experience
• Has a proven track record of publication in peer-reviewed journals.
• Has strong motivation to explore new technologies and concepts; experience with programming and AI is a plus.
• Appropriate level of understanding of applicable regulations
• Ability to communicate effectively both orally and in writing in an interdisciplinary environment; excellent interpersonal skills with the ability to interact effectively with people, internally and externally at all levels of the organization.
• Extensive knowledge and experience in solid-state chemistry, solid form and polymorphism or crystallization development.
• Extensive knowledge and experience of the drug development process and application of process chemistry and chemical engineering principles throughout the phases of drug process development.
• Ability to independently perform hands-on activities for process design and development, data analysis and interpretation; as well as collaboratively in order to cultivate strong team sprit within teams and groups.
• May require an ability to push, pull, lift and carry objects up to 50lbs.
• May require ability to wear a Respirator.

Desired Skills, Experience and Abilities:

• Sound knowledge and experience in developing cGMP isolation processes for chemical syntheses.
• Sound knowledge and experience in implementation of solid form screenings of organic compounds.
• Sound knowledge and experience of scale-up principles, thermodynamics and kinetics for applications/implementation of chemical processes.
• Sound knowledge and experience in applying advanced predictive and process modelling tools for process understanding and design.
• Sound knowledge and experience to apply AI and machine learning techniques to enhance process efficiency and productivity.

Compensation Data

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