External Manufacturing Technical Senior Manager
Gdańsk
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Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
(Senior) Technical Manager External Manufacturing (EM) will lead a cross-functional team for establishment of DP processes at external vendors and will provide technical oversight, trouble-shooting and commercial manufacturing expertise for Drug Product and / or Finished pack for assigned molecules/programs throughout the life-cycle. Technical Manager EM will report directly to the Head of External Manufacturing.
Your responsibilities:
- Lead / Coordinate DP program activities at CMOs in a cross-functional team, including establishment of filling processes, technical Transfers to CMOs, between CMOs and between CMOs and commercialization partners, i.e. act as a Technical Transfer lead.
- Support Drug product development with commercial manufacturing expertise and provide active support and advice throughout the molecule life cycle.
- Support / lead technical evaluations of Contract Manufacturing Organizations (CMO) in alignment with program requirements.
- Act as Subject matter expert (SME) for DP/FP manufacturing and support Changes and Deviation and provide support to Regulatory Affairs. Review / author related documents, if required.
- Act as Single point of contact for technical Inquires for DP/FP manufacturing from 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).
- Close collaboration with Program management, Drug product development, Quality, Supply Chain, Regulatory Affairs and related departments and their CMO counterparts.
- Support in the creation of internal procedures for CMO oversight and management, if required.
If you have:
- Over 5 years of experience in the (bio-)pharmaceutical industry, with direct experience with Biopharmaceutical products.
- Extensive experience in Manufacturing Science and Technology (MSAT), Technical Development, Production and/or other relevant operational areas with good technical understanding of aseptic manufacturing and related processes (e.g. visual inspection); experience with packaging and / or devices is a plus.
- Extensive experience with technical transfers of aseptic products, ideally biosimilars.
- Experience with commercial production, 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.
- Academic background in a relevant discipline (pharmacy, biotechnology, biochemistry, chemistry).
- Ability to work efficiently in a matrix organization with competing priorities.
- Ability to work in a global environment; intercultural competence.
- Ability to work independently, hands-on mindset.
- Very good command of English (speaking or willingness to learn Polish language is an advantage).
- Willingness for business travel to CMOs and internal sites.
What 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...
(Senior) Technical Manager External Manufacturing (EM) will lead a cross-functional team for establishment of DP processes at external vendors and will provide technical oversight, trouble-shooting and commercial manufacturing expertise for Drug Product and / or Finished pack for assigned molecules/programs throughout the life-cycle. Technical Manager EM will report directly to the Head of External Manufacturing.
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Polpharma Biologics
#PolpharmaBiologics 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. Chcielibyśmy, abyś do nas dołączył.