Chemist - mAbs Reviewer

at  Life Science Recruitment

CHEMIST/SCIENTIST - ANALYTICAL TECHNICAL STEWARD MABS

The Analytical Technical Steward 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 company and external requirements and is executed consistently to predetermined standards.
The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this.
Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support.

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.