Senior Technical Manager External Manufacturing
Gdańsk
Rozwijaj się z nami
Polpharma Biologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby. Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Dołącz do nas!
The role
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.
Responsibilities
- 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;
Requirements
- 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;
We offer
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package; hybrid work can be negotiated
- Additional free day;
- and more..
