Senior/Principal Scientist - Business Process and Validation (Biotech)

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.

Responsibilities:

As a Senior/Principal Scientist - Business Process and Validation (BPV) in the Kinsale Biotech TS/MS organisation, you will play a pivotal role in ensuring the success of our manufacturing processes. In addition to providing technical support for existing operations, you will actively contribute to the commercialisation, technology transfer and regulatory submission activities of new processes. Working within our dynamic team, you will closely collaborate with global and local functions, serving as a business user Subject Matter Expert on our exciting Digital Transformation Journey. Your expertise will truly shape the future of our operations. 

Key Responsibilities:

• Technical and Compliance Capability
• Possess in-depth knowledge of the science (including analytical aspects) behind the molecule and the entire process.
• Know the process control strategy for biotech drug substance processes, including upstream/cell culture and downstream/purification.
• Strong understanding of pharmaceutical regulations, quality standards and quality management systems.  Prepare for and support Health Authority inspections (FDA, HPRA, etc.). 
• Lead and enhance business processes through the strategic integration of internal and external expertise, acting as a business user Subject Matter Expert in our global Digital Transformation initiatives.
• Annual Product Reviews (APRs) Coordinator
• Responsible for overseeing the APR program across the Kinsale Biotech organisation and promoting innovation within the APR business process.
• Collate and review data related to product quality, process parameters, quality management systems and specifications.  Identify trends, assess process control and capability, and identify areas for improvement.  Use data-driven insights to enhance product quality.
• Liaise with Technical and Compliance Leaders, and cross-functional stakeholders to ensure processes remain in control, capable, and compliant.
• Process Validation Expertise
• Anticipate and resolve complex problems during the planning, authoring, and execution of process validation protocols and associated reports for Lilly’s products.
• Collaborate with manufacturing TS/MS, Statisticians, and Technical Leaders to support data trending, establish process limits, assess process control and capability, and maintain a validated state utilising the Ongoing Process Verification Process. 
• Collaborate with local and global stakeholders to provide the business user requirements, use cases and business process considerations as part of the TS/MS Digital Transformation Journey.
• Technology Transfer, Commercialisation and Regulatory Submission Activities
• Author technical documentation to support technology transfers, product commercialisation and regulatory submission activities.
• Collaborate with Subject Matter Experts and the Regulatory Affairs CMC organisation to contribute to the authorship and review of technical content for regulatory submissions and responses.
• Additional Skills and Preferences
• Able to establish strong relationships with key stakeholders within and outside the TS/MS function.  Empower new team members through training and mentorship. 
• Self-starter with a data-driven mindset.  Proficient in statistical tools for data analysis.  Demonstrated excellence in solving complex issues.
• High technical productivity and initiative with a proven track record of continuous learning and adaptability.
• Detail-oriented technical writing and verbal communication.
• Educational Requirements:
• MSc/PhD in Biochemistry, Cell Biology, Biotechnology, Microbiology, Analytical Science, Biochemical Engineering, or related discipline.  3+ years’ experience in a pharmaceutical manufacturing environment is preferable.

Join us in shaping the future of manufacturing through data-driven decisions, collaboration, and continuous improvement!

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly