Senior Bioprocess Scientist

4 days ago

Limerick, Ireland Eli Lilly And Company Full time

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.
The Senior Bioprocess Scientist will provide technical support for introducing and supporting advanced upstream cell culture manufacturing processes into the next-generation bioprocessing site in Limerick, from startup through to routine operations.
As part of the Technical Services/Manufacturing Sciences department, the ideal candidate will possess technical expertise in upstream bioprocessing, along with strong data-driven decision-making and problem-solving skills.
Additionally, they will leverage the advantages of a wholly digital plant to gain comprehensive process insights through data analytics and process analytical technology.
Key Responsibilities Knowledgeable of the science of upstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes.Understand purpose and capability of each upstream unit operation and the impact of equipment on the process.Provide technical support to the online process support team for process science, operational excellence, and compliance.Work as part of a cross-functional team at the interface between quality assurance, operations, and engineering to bring deep technical expertise and scientific rigor to the team.Utilize process monitoring tools to make data-driven decisions to ensure process consistency and robustness.Understand basic statistical methodologies and engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments, and analysis of batch data for summary reports and product reviews.Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance, and process monitoring needs are captured in manufacturing electronic documentation.Identify process improvements and participate in the implementation of Lean Manufacturing initiatives.Generate scientific reports and technical documentation.Understand and ensure compliance with safety, compliance, and regulatory expectations.Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.Attributes for the Role Demonstrated technical capability with high productivity.Proven track record of curiosity with learning agility.Self-starter with high initiative and data-driven approach to problem-solving.Demonstrated strong interpersonal skills.Demonstrated strong verbal and written communication skills.Demonstrated adaptability and flexibility to working in different environments, teams, etc.Demonstrated ability to participate in and facilitate decision-making.Educational Requirements: BSc or MSc in Biochemistry, Biology, Biotechnology, Chemical Engineering, or related discipline with relevant experience (>2 years' experience within the biopharmaceutical industry).
Work Environment: These are 8-hour day roles.
As a manufacturing support function, the need for occasional evening or weekend support can arise.
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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