Senior Manager
vor 1 Woche
**About HOOKIPA**:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.
This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.
HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.
**Position Summary**:
The function leads the operational team for Quality Control of outsourced production and testing of investigational medicinal products for HOOKIPA. This includes responsibilities in the pharmaceutical quality management system for Quality Control at external testing laboratories (release testing and stability testing), implementation and maintenance of related processes and procedures, as well as budget responsibilities to support the outsourced testing activities. The function acts as the responsible role in HOOKIPAs Technical Development Division for ensuring implementation and maintenance of product specifications, sampling instructions, concurrent analytical testing along with production, release of analytical results per issuance of CoA, related change management, investigation of OOS results and deviations, as well as RA filing of product analytics. The function liaises with method development, process development, Quality Assurance, and External Manufacturing as necessary to fulfill tasks of daily business and to support strategic development of the Technical Development Division.
**Main Responsibilities**:
- Establishment of appropriate procedures for analytical Quality Control (outsourced activity), its documented analytical test results review and issuance of CoA
- Ensure sufficient budget resources to conduct analytical tests as specified
- Build and manage appropriately educated and trained staff personnel to conduct analytical tests as specified
- Ensure appropriate stability programs to determine and confirm shelf life
- Ensure a sound and robust analytical tech transfer from R&D to GMP
- Adherence of department to rules and regulations for Quality Control of (investigational) medicinal products for human use
- Support the design, implementation, monitoring, and maintenance of the pharmaceutical quality management system for quality control operations
- Liaise with other departments - namely Research & Development, Quality Assurance, Manufacturing, and Project Management - to assure completion of Quality Control tasks according to program timelines
- Liaise with company executive management to establish and optimize company strategy for clinical development, manufacturing, and commercial supply of proprietary pharmaceutical products including company partnerships and licensing.
- Support Quality Assurance in relation to Quality Control activities during Regulatory Authority Inspections
- Contribute to the approval and management of external analytical control laboratories (supplier qualification process and audits)
**Qualifications & Skills**:
- University Studies degree (Master of Sciences or comparable level), in a Life Science area (pharmaceutical or medical sciences, biology, biochemistry, biotechnology, or comparable),
- Post-university education in pharmaceutical quality management (incl. quality control)
- Substantial experience in managing research cooperation projects with a specific Quality Management focus (ideally experience within clinical development, clinical research, and clinical trial environment in the biotech area)
- Substantial experience in outsourced activities for manufacturing of medicinal products incl. analytical testing (biological products preferred)
- Substantial Experience in team management and group leading specifically in the area of Quality Assurance and/or Quality Control.
- Scientific understanding and industry knowledge of biological and physical-chemical quality control and analytical testing of medicinal products (biological products and/or vaccines preferred)
- Abilities to lead and manage outsourced activities
- Hands-on knowledge of ICH, EU and US cGMP regulation
- Fluent in English, both spoken and written
**What we offer**:
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities fo
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