Analytical Team Leader- Quality Control
Ref No: SF17236
Cork, Co. Cork, Ireland
Analytical Team Leader- Quality Control, Cork
A client company is currently looking for an Analytical Team Leader in their API External Manufacturing Quality Control Laboratory
This role is a technical position helping to ensure that the analytical testing of products at multiple contract manufacturing (CM) sites meets requirements and is executed consistently to predetermined standards. The position is fast-paced, with multiple activities occurring simultaneously at potentially multiple CM sites. You will be reviewing data released by the contract manufacturer to ensure it meets expectations, review deviations for trends, review and/or releases stability data and lead resolutions of laboratory related manufacturing issues by performing in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of data and results. Additionally, the ideal candidate will represent the quality laboratories on cross-functional post-launch process optimization teams. The role works closely with development to ensure robust analytical control strategies are established in QC for the molecules they support.
- Technical review, interpretation, and release of data including release data from CM, stability, process validation, and reference standard characterization.
- Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Guides CMs to perform root cause analysis investigations and develop solutions to prevent reoccurrence.
- Develop investigational testing protocols and perform testing as required.
- Contribute to annual product review and process validation as required.
- Communicate effectively in both written and oral formats within the lab as well as with CMs and business partners.
- Participates in internal/external audits as needed
- Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
- Method assessments, deficiencies and areas for improvement noted within the assessments.
- Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
- Method validations (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in laboratory practices).
- Review of analytical test method packages
- Approval of test method protocols
- Approval of new test methods or changes or deletions to existing test methods
- Provide laboratory support (e.g., method development, validation and Method development work and implementation of method improvements for marketed products (including: laboratory work, training/transfer of new method to CM labs, change controls, and regulatory submissions).
- Implement new technologies into the CM Labs and improve existing methodologies.
- Improve assays in the CM Labs. These improvements include variability reduction, method optimization, and new method development.
- Local and Global Method Change Control Ownership
- Oversight over reference standard evaluations
- Selection of appropriate packaging materials
- Participate in the review of the reference standard profile and associated documentation for data integrity
- Consult in the preparation of the characterization protocol for corporate reference standards
- Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards
- Method transfers between QC labs and to CMs
- Oversee transfer of analytical methods for marketed products to CMs or other QC Labs.
- Monograph review and implementation
- Ensure consistent practices between global laboratories.
- Effective management of multiple projects.
Qualifications & Experience:
- Bachelor degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Biology)
- Experience in complex laboratory analysis in a cGMP laboratory, including, but not limited to chromatographic, spectroscopic, and/or microbiological assays.
- 5+ years’ experience supporting analytical aspects of monoclonal antibody clinical trial development and/or manufacturing
- Strong skills in making risk-based decisions and prioritization
- Deep understanding of cGMP compliance requirements and regulatory expectations
- Demonstrated accuracy and proficiency in analytical skills
- Demonstrated strong problem-solving skills.
- Strong oral and written communication skills and demonstrated through documentation and presentation skills
- Demonstrated strong interpersonal interaction skills
- Demonstrated experience with method qualification and validation
- Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations.
- Previous experience working with contract laboratories in a cGMP environment
- Training and demonstrated proficiency in root cause analysis methodology
- Must complete applicable Learning Plan
- May be required to provide 24 hour cell phone coverage
- May require up to approximately 20% of international travel
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