- JN -012024-1954379
- Jan 19, 2024
An experience Senior QC Analyst is required to join a global healthcare leader as a technical lead within mAbs.
The Senior Quality Control Analyst in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both internal and external requirements and is executed consistently to predetermined standards. The senior Quality Control Analyst also works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support.
- Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization.
- Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
- Develop investigational testing protocols and perform testing as required.
- Contribute to APR, tech transfer, and process validation as required.
- Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
- Participate in internal/external audits as needed.
- Develop and ensure execution of quality plan projects.
- Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
- Performs method assessments, with 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.
- Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in 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.
- Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions).
- Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
- Improve assays in QC. These improvements include variability reduction, method optimization, and new method development.
- Local and Global Method Change Control Ownership.
- Oversight of reference standard evaluations per Global Quality Standards.
- Selection of appropriate packaging materials.
- 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.
- Participate in the review of the reference standard profile and associated documentation for data integrity.
- Method transfers to Contract Manufacturers.
- Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
- Monograph review and implementation.
- Ensures consistent practices between laboratories running the same methods.
- Effective management of multiple projects.
- Bachelor degree in a science field related to the lab (e.g. Chemistry or Biochemistry)
- 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs
- Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay.
- Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines.
- Deep understanding of compliance requirements and regulatory expectations.
- Demonstrated accuracy and proficiency in analytical skills.
- Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
- Strong oral and written communication skills demonstrated through documentation and presentations.
- Ability to work in cross functional teams as well as across networks.
- Demonstrated experience with method qualification, validation, and transfer.
- Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules.
- Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV).
- Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
- Consultant | Life Sciences & Engineering Recruitment