Chemist - mAbs Reviewer

at  ScientificJobsie

Reference:AORASTC-816867
Location: Cork
Cork City
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
May be suitable for: Chemist, Scientist

BASIC REQUIREMENTS:

• Level 8 bachelor degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy)
• 5+ years of industry related experience in pharmaceuticals in a GMP lab
• Must have experience with mAbs

ADDITIONAL SKILLS/PREFERENCES:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay.
• Deep understanding of compliance requirements and regulatory expectations.
• Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
• 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).

• 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.