Analytical Project Lead

Duchnice, PL

Boost your career with us
Polpharma Biologics is a biopharmaceutical company with state-of-the-art facilities across Europe. Operating across international centers of excellence specialized in cell line development, product and process development, clinical manufacturing, commercial scale production and regulatory affairs, allows us to work and partner on our in-house biosimilar pipeline and at the same time provide top-quality contract development and manufacturing services to the industry.

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

Boost your career with us

Polpharma Biologics is a biopharmaceutical company with state-of-the-art facilities across Europe. Operating across international centers of excellence specialized in cell line development, product and process development, clinical manufacturing, commercial scale production and regulatory affairs, allows us to work and partner on our in-house biosimilar pipeline and at the same time provide top-quality contract development and manufacturing services to the industry.

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

As the Analytical Projects Lead, you will be responsible for overseeing projects carried out in the Analytical Development Department at Polpharma Biologics.

 

Your responsibilities include, but are not limited to:

 

  • Effective management of analytical projects, including oversight of schedules, budgets, scope of work, and resource allocation. Monitoring project progress to ensure their completion in line with established goals and timelines, while identifying potential risks and implementing corrective actions to optimize processes.
  • Coordinating and overseeing the process of commissioning studies to internal laboratory teams and external partners, ensuring that all assignments are executed in accordance with methodological, regulatory, and timing requirements. Efficiently managing communication with external partners to ensure timely delivery and high-quality results.
  • Collecting and systematizing research results from various sources, such as laboratory reports, certificates, and information systems. Creating an organized and easily analyzable dataset that supports accurate interpretation of results and decision-making at all stages of the project.
  • Developing comprehensive analytical documentation, including protocols, reports, and summaries, which form the foundation of regulatory documentation for biotechnological drugs.
  • Representing the Analytical Development Department during project meetings, presenting progress on project implementation, and communicating key information to stakeholders. Maintaining smooth internal and interdepartmental communication to ensure seamless collaboration and effective project management.
  • Ensuring that projects are carried out in accordance with the highest quality standards, including industry norms and internal organizational procedures.

 

If you have:

 

  • Minimum 5 years of professional experience in the pharmaceutical industry;
  • Higher education in the field of chemistry, biotechnology, biology, pharmacy, medicine, or related disciplines; a doctoral degree is an additional advantage.
  • Knowledge of the production processes of biopharmaceuticals, with a particular focus on the analytical testing of biologics.
  • Knowledge of regulatory guidelines for the registration of biopharmaceuticals, with an emphasis on preparing registration documentation, reports, and analytical protocols in compliance with the requirements of regulatory agencies (e.g., EMA, FDA) necessary for market authorization.
  • Experience in managing research and development projects in the biotechnology sector, including coordinating analytical processes, overseeing schedules, budgets, and resources, as well as communicating with internal teams and external research organizations.
  • Excellent presentation skills, including the ability to communicate information clearly, concisely, and persuasively, both in team meetings and presentations to internal and external stakeholders
  • Strong writing skills, including the ability to create clear, precise, and professional documents tailored to the needs of the audience and in line with applicable standards.
  • Proficiency in English, both written and spoken.
  • Excellent organizational skills, including effective time management to ensure timely achievement of set goals.
  • Advanced knowledge of Microsoft Office, including Excel, Word, and PowerPoint, and experience working with MS Project, statistical software (e.g., JMP, Statistica, GraphPad).

 

What we offer:

 

  • Competitive salary; 

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Additional free day;
  • and more..
Why you should work with us