Careers

Senior QA Specialist/Manager, QA Operations

Description

Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com

We are seeking a highly motivated individual to join as a Sr. QA Specialist/Manager of QA Operations. This individual will report into the Sr. Manager (Head of) QA Operations and play an essential role in maintaining and supporting a reliable and compliant supply of Harpoon products to clinical sites.

KEY RESPONSIBILITIES

  • Primary responsibilities entail working with internal (CMC/product development) and external stakeholders (CMOs) to meet Harpoon’s timelines for finished drug product release (IND enabling and routine clinical trial supply).
  • Assist with Harpoon Quality Unit review and approval of CMO master documentation (e.g. specification documents, master batch records, label proofs, etc.) as well as executed batch records, QC release records, and stability test records for the manufacturing of cell banks, drug substance, drug product, final drug product, and diluent.
  • Work with Qualified Persons (QPs) to support QP certification for distribution of Harpoon products to EU/UK clinical trial sites (Annex 16).
  • Support QA oversight of stability protocol data review and expiry dating of Harpoon products
  • Work with internal stakeholders and/or CMOs to perform deviation investigations in support of product quality (as applicable)
  • Work with internal stakeholders and/or CMOs to initiate and implement change controls
  • Participate in GMP compliance audits and complete risk assessments for supplier qualification (as required)

Skills and QUALIFICATIONS

  • BS/MS in Science or Engineering with at least 5 to 7 years in a Quality Operations or manufacturing role, in a late stage or early stage start-up biotechnology/pharmaceutical company
  • Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for biologic drug substance and finished drug product. This could be a combination of working in Quality Operation/Manufacturing roles
  • Experience in aseptic validation and aseptic processing a plus (e.g. media fill program evaluation).
  • Some level of experience in auditing CMO sites for GMP compliance, Quality Systems and assessing process capability
  • Working level knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification
  • Appreciation of quality risk management concepts
  • Proficiency in ICH Q10 requirements
  • Working knowledge of 21CFR US FDA regulations, ICH guidance, and Eudralex GMPs
  • Strong negotiation and influencing skills with internal and external stake holders
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work both independently and collaboratively in a fast-paced matrixed environment