At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

LRL Business Integrator – Product Research and Development (CMC)

At Lilly, we unite caring with discovery to improve life for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, USA, our 39,000 employees work to discover life-changing medicines, enhance disease understanding and management, and support our communities through philanthropy and volunteerism. Guided by our values of putting people first and giving our best effort, we are looking for individuals who share our determination to make life better for people everywhere.

We are seeking a CMC Business Integrator with expertise in Product Research and Development (CMC) to serve as the bridge between business scientists and technology teams. This role involves capturing detailed process flow diagrams, conducting data analysis, and creating comprehensive business process flow mappings to streamline CMC workflows. Additionally, the integrator will help automate technical reporting within the CMC domain, leveraging data-driven insights and advanced tools to enable efficiency and innovation.

Key Responsibilities

Process Flow Mapping and Collaboration

Collaborate closely with business scientists to understand and document detailed process flow diagrams for Product Research and Development (CMC).

Capture critical unit operation parameters and ensure accurate representation in business process flow mappings.

Facilitate workshops and discussions to align stakeholders on current workflows and identify gaps or improvement areas.

Data Analysis and Technical Insights

Perform in-depth data analysis to identify trends, predict stability data, and assess impurity profiles in the CMC domain.

Work with stakeholders to interpret data insights and drive decisions that enhance process optimization and scalability.

Collaborate with scientists to consolidate and structure data to support regulatory submissions and process development.

Automation of Technical Reports

Partner with technology teams to design and implement solutions for automating technical reports generated within the CMC area.

Define business requirements for automation projects, ensuring alignment with operational needs and regulatory standards.

Validate automated report outputs to ensure accuracy, reliability, and compliance.

Technology Integration and Optimization

Support the integration of digital systems and tools for capturing and automating CMC workflows, such as LIMS, MES, and reporting platforms.

Ensure seamless communication and data flow between CMC systems and enterprise platforms to enhance operational efficiency.

Leverage technology to streamline tech transfer processes, enabling efficient knowledge and data sharing.

Regulatory and Compliance Support

Ensure adherence to global regulatory requirements (FDA, EMA, ICH) in all automated processes and reporting outputs.

Provide support for regulatory submissions by delivering accurate and automated technical reports.

Stakeholder Engagement

Act as the key liaison between business scientists, IT teams, and other stakeholders to translate business needs into technical requirements.

Facilitate alignment between business goals and technology solutions, ensuring clarity and effective collaboration.

Required Skills

Education

Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related field.

Experience

5+ years of experience in CMC-related roles within the pharmaceutical, biotechnology, or related industries.

Proven expertise in capturing and analyzing business process flows, particularly within the Product Research and Development (CMC) domain.

Hands-on experience with digital tools for reporting, process mapping, and data analysis.

Strong familiarity with regulatory requirements, including FDA, EMA, and ICH guidelines.

Skills

Proficiency in creating and analyzing process flow diagrams and business process flow mappings.

Advanced data analysis skills, with experience in tools like Python, R, Spotfire, or Tableau.

Strong technical aptitude and experience in report automation using enterprise tools.

Exceptional communication and interpersonal skills for working with cross-functional teams.

Ability to effectively manage multiple projects and deliver results in a dynamic, regulated environment.

Preferred Qualifications

Familiarity with digital tools such as LIMS, ELN, MES, or process mapping software (e.g., Visio, Lucidchart).

Experience in automating technical reports or workflows within regulated environments.

Knowledge of product development and manufacturing processes for CMC.

Understanding of emerging technologies in digital transformation for CMC.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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