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..
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.