Manufacturing Manager Drug Product đź’‰
Are you a specialist in biologics manufacturing looking to manage high-impact projects in commercial production? This role offers a opportunity to lead and coordinate at the forefront of innovation!
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.
- Avdelning
- Technology
- Role
- Life science
- Locations
- Stockholm
Stockholm
Why team up with Wrknest?
-
Potential
Vi tror att personer med rätt potential kan lära sig mycket. Därav tittar vi inte primärt på vad ni historiskt har gjort utan vad ni kan lära er framåt. -
Onboarding
Vi tar ansvar för att tillsammans med arbetsgivare att ge dig en gedigen onboarding. Något som vi vet ökar ditt engagemang och som kommer göra dig mer bekväm i rollen. Detta kommer göra att du utvecklas snabbare på arbetsplatsen och att din karriär tar fart. -
Upskilling
Vi tror på att individer behöver konstant utvecklas och att man kommer in i det eviga lärandet. Därför erbjuder vi skräddarsydda utvecklingsprogram för alla våra konsulter.
About Wrknest
Manufacturing Manager Drug Product đź’‰
Are you a specialist in biologics manufacturing looking to manage high-impact projects in commercial production? This role offers a opportunity to lead and coordinate at the forefront of innovation!
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