Job Details

Quality Control Manager – Contract Assignment 

You will be responsible for managing GMP release and stability testing in support of clinical programs while ensuring compliance with SOP’s, policies, and industry guidance. In addition, this role will be responsible for leading, facilitating and supporting US and Global processes for harmonizing and integration of stability-related activities and supporting various GMP Quality Systems. This includes, but not limited to, creating, implementing, and managing stability LIMS, performing data trending and statistical analysis, forecasting, and approval of stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. 

Job Responsibilities:

• QC Subject Matter Expert for release, stability, and compendial methods, sampling plans, method lifecycle management, deviations, OOS/OOT and testing investigations, root cause analyses, and CAPAs.
• Provide characterization and assay support for DS and DP early and late-stage clinical programs.
• Manage reference standard qualification, inventory, and bridging.
• Manage and provide oversight for CDMO placebo, DS, and DP stability studies including CDMO documentation review, study design, sample management, data review, and trending analysis.
• Plan, manage, and communicate stability pull dates and ensure stability testing occurs within specified testing windows.
• Review CDMO stability testing packages, perform statistical trend analysis, provide stability updates, and manage internal QC data requests.
• Set DS and DP shelf lives with internal stakeholders to ensure uninterrupted clinical supply.
• Proactively manage mitigation and resolution of stability related issues such as OOS/OOT stability results or adverse stability trends
• Manage QC review of release/stability method qualifications and validations.
• Perform QC review of release data and issue CoAs.
• Manage cell bank, DS, DP, and placebo release and stability GMP specifications including justification of specifications and specification revisions.
• Support ongoing development of GMP analytical methods for in-process and lot release/stability testing of drug substance and drug products.
• Manage clinical site product temperature excursion QC impact assessments

Minimum Qualifications:

• BS/MS with 7+ years of industry experience.

Preferred Qualifications:

• Strong knowledge of QC principles, concepts, industry practices, and standards.
• Experience in characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as HPLC, CE, CIEF, and mass spectrometry (MS), as well as biophysical characterization methods.
• Strong knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release / stability testing.
• Extensive knowledge of cGMP regulations and guidelines.
• Demonstrated experience, and independence with QC functions associated with the GMP production and testing of biologics in clinical and/or commercial settings.
• Demonstrated ability to work effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables.
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
• Excellent written and verbal communication skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to prioritize and adjust workload based upon changing priorities.
• Experience using LIMS system a plus.