Head of Drug Substance MS&T

2 tygodni temu

Gdańsk, Pomerania, Polska Window World of Boston Pełny etat

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Head of Drug Substance MS&T Boost your career with us Boost your career with usPolpharma 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 hopeto patients suffering from serious diseases. We create a passionate andfriendly workplace environment. Join us

As the Head of MS&T (Manufacturing, Science & Technologies) Drug Substance, you are responsible for leading a team to ensure complex technical changes, technology transfer initiatives, process research, validations, and legal commitments. You'll be managing a team tasked with supporting the TR&D team in developing scalable, cost-effective, efficient processes, driving improvements, transferring processes, and

scaling up to manufacturing sites according to plans.

This role, as part of the Leadership Team, is accountable for developing both a high performing MSAT organization and being active in building the overall culture to create a state-of-the-art manufacturing facility for Polpharma Biologics.

Your responsibilities include, but are not limited to:

Leadership

  • Leading the MS&T employees to deliver high-performance
  • Driving the development of the MS&T team members
  • Developing and organizing the team, supporting through projects and structure changes
  • Retains develops, or acquires top talent capable of meeting MS&T department job functions. Ensure MS&T personnel is assigned and maintains appropriate site GMP training courses
  • Ensuring budget is available and managing spending accordingly
  • Providing technical guidance and scientific expertise to the MS&T team
  • Creating a culture of accountability, and innovation within the MS&T organization with a focus on customer service to manufacturing and manufacturing support functions

Technical

  • Providing manufacturing perspectives in the development of new products and deep insights on state-of-the-art manufacturing and validation practices
  • Supporting the regulatory process by writing, reviewing and approving applicable sections in registration files and variations
  • Authorizing and executing studies and protocols to generate and analyze data and well as author reports needed to support product and process development, troubleshoot processes and methods, and validate new processes
  • Providing technical expertise over complex issues. Coordinates technology transfer, scale-up as well as process validation (PPQ batches)
  • Functioning as technical change owner through GMP change management processes for new and/or improved products, equipment, and processes through implementation, validation, and startup activities in highly regulated environments,
  • Collaborating with manufacturing and engineering teams to ensure manufacturing lines run in a state of control producing product capable of meeting product specifications
  • Supporting technical challenging deviation investigations, identification and implementation of effective corrective and preventive actions (CAPA)
  • Authorizing responses to process/validation related Audit requests;
  • Developing a quick understanding of the skills and tasks associated with other functions so projects can be driven and executed successfully

If you have:

  • PhD/Master's degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy or related.
  • At least 8 years' experience in technology/biopharmaceutical process development.
  • Experience leading groups involved in technology development and process transfer in a biopharmaceutical/ biotechnology manufacturing environment.
  • Strong scientific background in biological processes ( (mammalian) and products in development, scale up, technology transfer and operations.
  • Significant experience in process validation and cleaning validation.
  • Strong working knowledge of GMP.
  • In-depth experience in biopharmaceutical technologies including large-scale Cell Culture technologies, and manufacturing of proteins.
  • Excellent verbal and written communication skills in English.
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