About Lilly:
We unite caring with discovery to make life better for people around the world. As a global healthcare leader, we give our best effort to our work and put people first. We're looking for determined individuals who want to make a difference.
Job Description:
At Lilly's new Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland, we're creating a technically advanced manufacturing site with state-of-the-art technologies and data collection platforms. This greenfield facility will enable us to deliver improvements in safety and quality, increase productivity and process performance.
Role: Senior Principal Scientist - Bioanalytical
As a key member of our Quality Control team, you'll provide analytical leadership for all aspects of bioanalytical technologies and methods. You'll be responsible for developing and implementing analytical methodologies, equipment, systems, and processes to run our laboratory to the highest standards of technical and operational excellence.
Key Responsibilities:
1. Lead the introduction, validation, and ongoing technical agenda for pipeline and commercial analytical methods and technology.
2. Develop and validate robust scientifically advanced methods with required performance attributes to satisfy stakeholder needs.
3. Execute and/or oversee testing protocols in accordance with biosafety, local procedure, and regulatory requirements.
4. Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
5. Collaborate with Bioproducts Research and Development to develop and transfer new techniques and methodologies.
6. Establish connections with other manufacturing sites to deliver their support needs.
7. Provide training or mentorship to QC or cross-functional team members as required.
8. Act as Subject Matter Expert (SME) for molecular and chromatographic-based analytical technologies.
9. Ensure accurate receipt, storage, analysis, and disposal of samples, including outsourced testing.
10. Investigate non-conformities using Root Cause Analysis techniques and implement countermeasures.
11. Stay up-to-date with scientific literature, new technologies/capabilities, and regulatory initiatives/requirements, and support implementation as necessary.
12. Support writing Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs).
13. Participate in self-inspection or audits, focusing on analytical aspects of cGMPs.
Leadership/Site Management:
1. Proactively support management decisions and strategy.
2. Model high-performance behaviors and prioritize quality control activities.
3. Influence business/external partners on critical issues to meet end goals.
4. Attend and contribute to relevant internal and external technical forums.
Pre-Requisites:
Candidates must be able to travel to US-based locations for familiarization and training.
1. Excellent laboratory techniques with safety as priority.
2. Deep technical expertise in molecular and chromatographic techniques with ability to interpret/experiment outcomes.
3. Strong problem-solving skills in independent and team settings.
4. Motivation to produce high-quality work independently and effectively.
5. High attention to detail in all aspects of work.
Educational/Experience Requirements:
- BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology, Biology, or related field with minimum 7 years' recent experience preferably in a QC laboratory environment.
- Experience with molecular testing (e.g., ELISA assays, qPCR assays) and separation testing (e.g., HPLC, UPLC, CE, iCIEF assays).
Additional Skills/Preferences:
- Strong written and oral communication skills
- Ability to work independently, self-sufficiently, and proactively in the performance of work duties.
- Conflict resolution and decision-making skills among team members
- High learning agility and flexibility to achieve required outcomes
- Imaginative approach to problem solving and solution discovery
Key Attributes:
- Business Knowledge: Demonstrated high performance in delivery of work, initiative, and proactive actions. Self-management, prioritization, and organizational skills are essential.
- Learning Agility and Curiosity: High learning agility and flexibility to deal with ambiguity and uncertainty. Identifying and prioritizing problems, developing and implementing solutions is crucial.
- Positive Influence: Demonstrated ability to address issues promptly and take action. Team trust and interest in personal performance improvement are vital.
- Relationship Builder: Demonstrated ability to establish and maintain relationships across levels within the organization.
- Ability to Lead People: Demonstrated leadership and motivation in a team environment. Influencing peers and functions is also essential.
- Communication: Demonstrated strong communication skills in both 1:1 and group situations.
- Decision Making: Demonstrated ability to make well-informed decisions for the benefit of the team. Collecting necessary information and asking appropriate questions of peers is crucial.
Lilly is committed to equal opportunities and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.