Product Quality Lead (Biosimilars)
Duchnice (pow. warszawski zachodni)

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

As the Product Quality Lead assigned to Biosimilar projects your responsibility will be to ensure appropriate quality of development, production and product lifecycle management. You will represent Polpharma Biologics Quality Dpt. in cross-functional project teams with responsibility for oversight of the overall quality of the project from late stage development process, scale-up and technical transfer to commercial scale, including establishment and guidance on quality requirements for manufacturing and analytical activities related to clinical Ph 1-3 stages, PPQ, filing and life-cycle management of products post approval. You will also coordinate Quality activities for the Biosimilar program across internal Polpharma Biologics network (Utrecht, Gdansk and Duchnice), as well as external.

Your responsibilities

  • Representing Group Quality of Polpharma Biologics for Biosimilar program, supporting Polpharma Biologics Biosimilar Program Lead by coordinating all Quality sites and functions, and by working collaboratively with line function units (i.e. facilities, engineering, scientific experts) to support establishment of biosimilar production and testing facilities at internal or external sites
  • Providing expert quality guidance related to quality standards, relevant quality guidelines, regulations and requirements for biosimilar manufacturing and testing, in both clinical and commercial phase
  • Providing QA guidance for cell bank management, process and analytical development, including support in defining appropriate analytical requirements for biosimilars
  • For the assigned projects, overseeing the overall quality of the late stage development, technical transfer to GMP manufacturing, preparation for process and analytical method validation, stability, and release activities for internal and 3rd party network
  • Working individually and in cooperation with others to ensure adequate Quality Oversight of manufacturing, and manufacturing/supply of raw materials and cell banks
  • Reviewing and approving product test methods, specifications, and protocols/reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, on-going process verification
  • Representing Quality for Regulatory filing strategy, perform review of CMC sections as required for initial submissions and during lifecycle management of the biosimilar
  • Providing Product Quality Stewardship for the biosimilar by assessing and providing decisions with respect to Change Control management across sites
  • Performing assessment of deviations, investigations, CAPAs, and change controls, specification, protocols, etc. as needed
  • Providing on-site support for Prior-Approval Inspections for the biosimilar products
  • Consolidating Annual Product Review / Product Quality Review for the overall supply chain (DS / DP / FP / MD)

If you have

  • Master’s or doctoral degree in a relevant field (pharmacy, biotechnology, biochemistry, chemistry)
  • 10 or more years of experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products.
  • Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and/or project management experience
  • Significant experience with manufacturing and/or testing of Monoclonal Antibodies derived cell culture Drug Substance / Drug Product (fed-batch or perfusion processes)
  • Solid experience with Validation, Technical Transfers, Launches, Lifecycle Management of Products
  • Experience with third-party management
  • Experience with US FDA PAI
  • Solid management skills with respect to planning/tracking, prioritizing and project timelines
  • Excellent written and oral communication and presentation skills
  • Excellence in influencing people without direct authority, negotiation, and communication
  • Excellent technical writing skills
  • Fluency in English (spoken and written)

We offer

  • Company car
  • Private healthcare
  • Cutting-edge technology equipment
  • Attractive salary
  • International work environment
  • Relocation package
  • And much more…
Join our Team!

Why you should work with us