Surface Oncology

Senior Manager, QC and Stability

RESPONSIBILITIES:

  • 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:

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