Downstream Bioprocess Scientist - Technical Services/Manufacturing Sciences
Eli Lilly
- Limerick
- Permanent
- Full-time
- Knowledgeable of the science of downstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes
- Understand purpose and capability of each downstream 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 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 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
- 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
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.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