Manufacturing Specialist

Manufacturing & QC Specialists (GMP) – Advanced Cell & Viral Vector Production

Location: Zeytinburnu, Istanbul, Türkiye (On-site)

Employment Type: Full-Time

About Biruni University

Biruni University is building Türkiye’s leading center for cell & gene therapy. Our GMP cleanroom facility (completion this year) will support clinical-grade manufacturing of viral vectors and engineered immune-cell products. To accelerate know-how transfer, we offer a fully funded 3-month training placement at Harvard University for eligible hires (advanced bioprocessing & QC systems).

Position Overview

We are hiring two complementary profiles under one posting:

• Manufacturing Specialist – lead clinical-grade cell processing and viral vector–enabled workflows.
• QC Specialist – lead release/stability testing, method validation, and GMP quality systems.

Candidates may be considered for either track based on experience.

Core Responsibilities

Manufacturing:

• Cell processing: Isolate, activate, transduce, expand, and harvest human immune cells using aseptic and closed-system techniques.
• Viral vector integration: Execute upstream/downstream steps for ex-vivo engineering (transduction parameters, MOI optimization, harvest/hold).
• GMP operations: Support facility/equipment qualification (IQ/OQ/PQ), environmental monitoring awareness, and cleanroom behaviors.
• Tech transfer & scale-up: Run engineering and validation lots; contribute to batch records (BPRs), SOPs, deviations/CAPA .
• Equipment oversight: Incubators, biosafety cabinets, automated/closed expansion systems, cell counters/flow cytometry (user level).

QC:

• Release & stability testing: Execute in-process controls and lot-release assays (e.g., cell identity/viability, purity, potency), manage stability pulls.
• Method lifecycle: Assist with method qualification/validation, reference standards, and trending .
• Documentation & QMS: Maintain GMP-compliant records (SOPs, test methods, raw data, LIMS/ELN entries); support deviations/CAPA, change control .
• Environment & compliance: Coordinate with EM/Microbiology for cleanroom trend reviews; support data integrity and audit readiness.

Qualifications:

• PhD in Biotechnology, Molecular Biology, Immunology, Biomedical Engineering, or related field (MSc with strong industry GMP experience considered).
• Required: Hands-on GMP experience in either cell-therapy/biologics manufacturing or QC of advanced therapies.
• Solid grasp of cell biology, aseptic techniques, and (for Manufacturing) viral transduction/bioreactors; (for QC) analytical methods for ATMPs.
• Familiarity with EMA/FDA expectations for ATMPs, data integrity, and documentation.
• Strong English (written/spoken); meticulous documentation habits.

Why Join Us

• Paid 3-month Harvard training (eligible candidates).
• Build a flagship cell & gene therapy hub in Türkiye.
• Work alongside scientists, clinicians, and regulatory experts with clear career paths across Manufacturing, QC, and CMC.

Application Process

• Submit CV + a concise cover letter indicating your preferred track (Manufacturing or QC) and summarizing your GMP experience (e.g., # of clinical lots, methods validated, cleanroom grades, platforms used).