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Job Description

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the technical capabilities to enable a successful startup of cGMP manufacturing operations.

Job Title:

Senior Principal Scientist- Bioanalytical.                                             

Outline of Role:

The Senior Principal Scientist (Bioanalytical) role in Quality Control provides the analytical leadership for all aspects of bioanalytical technologies and methods. This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects.

Specifically, during the startup phase of the Limerick site (2023 to 2026) the Senior Principal Scientist (Bioanalytical) will be expected to be a collaborative, inclusive, energetic technical leader and support the broader Limerick technical team to:

Build the necessary technical capabilities to operate the laboratory facility to the highest standards of technical and operational excellence.

Develop and implement the analytical methodology, equipment, systems, and processes needed to run the laboratory – leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.

Ensure regulatory compliance and operational excellence by supporting lean principles and a digitally native approach.

Support the project team as they deliver the laboratory facility to the site team, by providing feedback and support on decisions and strategies to meet project deliverables and longer term strategic goals for the site.

Key Responsibilities: 

Senior Principal Scientist (Bioanalytical):

Lead the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.

Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.

Execute and/or oversee testing protocols in accordance with biosafety, local procedure and regulatory requirements.

Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.

Develop strong links with Bioproducts Research and Development and participate in the development and transfer of new techniques and methodologies.

Develop strong links with other manufacturing sites to deliver their support needs.

As required provide training or mentorship to other QC or cross functional team members.

Act as SME for molecular and chromatographic based analytical technologies. This may include the identification, sourcing, installation, and qualification of new equipment.

Assure that all samples are appropriately received, stored, analysed and disposed of appropriately. This also includes testing outsourced to third parties.

In the event of non-conformance to acceptable quality and/or safety standards, lead, and document analytical investigations using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are appropriately implemented.

Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.

Support the writing of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs).

Support and participate in self inspection or other audits with particular reference to the

analytical aspects of cGMPs as defined by the Health Authorities, and Food and Drug Administration.

Leadership/ Site Management:

Proactively support management decisions and strategy.

Be a role model and mentor for Quality Control team members in terms of performance and behaviours.

Influence business/external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.

Attend and contribute to relevant internal and external technical fora.

Pre-Requisites (Includes experience, qualification etc)

Candidates must be able to travel to US based locations for familiarisation and training. Duration and frequency will be dependent on experience levels and site goals.

Job specific pre-requisites:

With safety as the priority excellent laboratory techniques.

Deep technical expertise in molecular and chromatographic techniques with the ability to interpret / understand the outcome of and linkages between experiments.

Strong technical problem-solving ability both working independently and as part of a team.

Motivated to work independently to produce high quality work in an effective manner.

High attention to detail in all aspects of the work.

Educational/Experience Requirements

BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology,  Biology or related field with minimum 7 years of recent experience preferably in a QC laboratory environment.Experience with molecular testing, such as ELISA assays, qPCR assays.Experience with separation testing, such as HPLC, UPLC, CE, iCIEF assays.

Additional Skills/Preferences:

Strong written and oral communication skillsAbility to work independently, self-sufficiently and pro-actively in the performance of work duties.Ability to resolve conflict, and promote good decision making among team membersHigh learning agility and flexibility to achieve the required outcomes.Imaginative approach to problem solving and solution discovery

Key Attributes: (These will be what are used to assess the candidates)

Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.Positive Influence: Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions.  Is interested in own performance and seeks feedback to improve.Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team.  Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.

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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