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.
Post : LRL PR&D Business Integrator – Product Research and Development (CMC)
Job Description
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.
Candidate Profile
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.
Additional Information
Experience : 5+ years
Qualification : Bachelor’s or Master’s degree
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Product Research and Development (CMC)
End Date : 25th January 2025
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