Manufacturing Manager Drug Product 💉

Publiceringsdatum: 2024-11-18

Har du övervägt att arbeta inom naturvetenskap-branschen? Det är nu möjligt för dig att få jobb som civilingenjör, bioteknik hos Wrknest AB. Intresserade sökes för heltid-jobb hos Wrknest AB - är du intresserad? De letar efter någon som vill jobba 6 månader eller längre.

Platsen där jobbet finns ledigt är i Stockholm. Företaget Wrknest AB erbjuder just nu spännande karriärmöjligheter. Om du vill jobba som civilingenjör, bioteknik har de nu ett ledigt jobb - kolla in annonsen för att se om du har rätt erfarenhet. Du har fortfarande tid att söka jobbet som civilingenjör, bioteknik hos Wrknest AB om du sickar in din ansökan senast sista ansökningsdag som är onsdag den sjunde maj 2025.

Jobbannons

About the Role Our client isseeking a Manufacturing Manager in the pharmaceutical sector for a consulting assignment of 6 months, with the possibility of extension and potential permanent hire. This role focuses on serving as a subject matter expert (SME) in biologics drug product (DP) manufacturing and leading coordination efforts for activities across cross-functional teams and external stakeholders.

Key Responsibilities In this position, you will:

• Act as an SME for DP processes in commercial manufacturing, particularly in aseptic filling for vials and syringes.
• Ensure adherence to cGMP standards, investigate deviations, and propose corrective actions.
• Oversee and coordinate activities with CMOs, including technology transfer and process validation.
• Compile data from validations and studies, and contribute to regulatory documentation and responses.
• Support preparations for new market launches and interactions with commercial partners.
• Participate in sourcing, supplier qualification, and drafting MAA/BLA documentation.

What We’re Looking For You bring experience in:

• Sterile product manufacturing processes in commercial settings.
• Technology transfer and process validation for drug products.
• Aseptic fill-and-finish operations for vials and syringes.
• Creating CPV plans, risk assessments, and regulatory reports.
• Writing and managing BLA/MAA documentation and regulatory interactions.

A degree in Chemistry, Biotechnology, or equivalent is required, along with proven experience in the pharmaceutical or biotech industries. Fluency in English is essential, while knowledge of Swedish is an advantage. Strong organizational and communication skills are key for managing internal and external stakeholders.

Additional Information

Start: Immediate or as agreed.

Location: Stockholm.

Scope: Full-time.

Employment Form: 6-month consulting assignment via Wrknest, with a possibility for extension or permanent employment.

About the Client The client is a pioneering biotech company developing high-quality biologics for global markets. They collaborate with leading industry partners and are committed to advancing therapeutic innovations.

About Wrknest At Wrknest, we do things differently. We challenge traditional recruitment by focusing on potential and continuous learning. In a rapidly evolving digital world, skills must stay relevant. That’s why we go beyond the resume, offering tailored upskilling to match current demands. Learn more at www.wrknest.se.