Manufacturing Manager Drug Product 💉

About the Role
Our client is seeking 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.

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