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External Manufacturing Technical Senior Manager.

Polpharma BiologicsGdańsk

Ponad 30 dni temu

Opis pracy

Opis stanowiska

podany przez pracodawcę :

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...

Wymagania stawiane pracownikowi :

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