Senior Manager, QC and Stability
- Design, implement and manage phase appropriate stability program including stability protocol review, management of data, completion of stability reports and completion of relevant change controls and regulatory submissions.
- Support all GxP outsourced stability and product testing including method development, feasibility, qualification, transfer, test results and reporting.
- Supports the coordination with Quality and Program Managers to provide project updates, workflows, and timelines.
- Support outsourced testing laboratories laboratory investigations
- Provide tracking and trending of product test results (non-stability)
- Contribute to characterization, analytical, and stability sections of regulatory submissions.
- Manages Analytical CMC activities for process validation activities for early stage programs.
- Provide technical expertise, trouble shooting and assay development to support external analytical development and quality control.
- Perform data review including release and stability testing.
- Maintain analytical metrics for the Quality Management Review program.
- Author technical documentation (e.g. SOPs, policies, forms, etc.) for phase appropriate related to testing.
- Contribute to Out of Trend (OOT) or Out of Specification (OOS) investigations.
- Must be a team player and open to change.
- Must have excellent communication and public speaking skills. Can make presentations on validation and release/stability activities.
- On time and compliant completion of external method validation to support lot release.
- Timely delivery of outsourced release and stability results.
- Significant contributions to Quality department/Surface goals and objectives.
EDUCATION AND EXPERIENCE:
- 8+ years of experience in Quality Control/GMP laboratories required.
- Experience with testing and/or management of stability testing strongly preferred
- Established background in analytical development and/or technical QC GMP experience.
- Experience with vendor management of CMOs and/or CTLs for Drug Substance and Drug Product programs is preferred.
- Experience in the bioassay/analytical testing is preferred
- Ability to work independently and in compliance with cGMPs.
- Expertise in ICH guidelines, USP/EP.
- Excellent team skills, organization, and strong.
CONTACT: Please submit the form below: