Senior Technical Manager External Manufacturing

As a Senior Technical Manager, External Manufacturing (EM) you will work in a cross-functional team to provide technical oversight, troubleshooting, and commercial manufacturing expertise in Drug Product and/or Finished packing. Furthermore, you manage technical transfers in alignment with program timelines and report directly to the Head of External Manufacturing.

• Support/lead technical evaluations of Contract Manufacturing Organizations (CMO) in alignment with program requirements;
• Support Drug product development with commercial manufacturing expertise and provide active support and advice throughout the molecule life cycle; 
• Act as a Subject matter expert (SME) for DP/FP manufacturing and support Changes and Deviation and provide support to Regulatory Affairs;
• Lead Technical Transfers to CMOs, between CMOs, and between CMOs and commercialization partners, as required by assigned programs, i.e. act as a Technical Transfer lead;
• Collaborate with Program Management, , Supply Chain, Regulatory Affairs, and related departments and their CMO counterparts; 
• Act as a single point of contact for technical inquiries for DP/FP manufacturing from the program team and CMOs regarding assigned molecules (i.e. act as product steward); support Health Authority and partner inspections (e.g. PAI at assigned CMOs);
• Assist in creating internal procedures for CMO oversight and management, if required;

• Minimum 5 years of experience in the (bio-)pharmaceutical industry, with direct experience with Biopharmaceutical products;
• Academic background in a relevant discipline (pharmacy, biotechnology, biochemistry, chemistry);
• Extensive experience in Manufacturing Science and Technology (MSAT), Technical Development, Production and/or other relevant operational areas with a good technical understanding of aseptic manufacturing and related processes (e.g. visual inspection);
• Proven track record with technical transfers and commercial production of parenteralia, ideally biosimilars;
• Experience working with or for contract manufacturing organizations (CMO/CDMO);
• Thorough knowledge of cGMP requirements;
• Good understanding of regulatory requirements for commercial pharmaceutical or biological products;
• Ability to work efficiently in a matrix organization  with competing priorities in a global setting;
• Capability to work independently and with a hands-on approach;
• Very good command of English; speaking or willing to learn Polish would be advantageous;
• Willingness for business travel to CMOs and internal sites;

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package; hybrid work can be negotiated
• Additional free day;
• and more..