Manufacturing Project Lead

10 hours ago


Malmo, Skåne, Sweden Magle Chemoswed AB Full time

Company Overview

Magle Chemoswed AB is a dynamic and growing company that supports life science companies through CDMO services and develops and manufactures its own products with DSM technology. We are looking for a skilled Commercial Manufacturing Project Manager to join our project team.

Job Description

As a Commercial Manufacturing Project Manager, you will play a crucial role in ensuring the successful coordination and timely release of commercial production batches. You will oversee all critical activities, from production start-up through to final product release, serving as the key link between multiple teams.

Key Responsibilities

  • Collaborate with teams in QC, QA, Production, R&D, Supply Chain, and Engineering to ensure operational readiness.
  • Effectively manage project timelines, risks, and resources to achieve on-time and on-budget delivery.
  • Lead and coordinate commercial production projects, ensuring timely product release through effective cross-functional alignment.
  • Provide support in Tech Transfer, managing the smooth transition from development to production, ensuring operational continuity and compliance.
  • Ensure adherence to regulatory and quality standards, especially GMP and medical device regulations.
  • Serve as a liaison between internal teams and external stakeholders, facilitating clear communication and alignment.
  • Handle customer communication regarding deliveries for commercial batches, ensuring customers are informed of timelines, potential delays, and any changes.
  • Drive and optimize processes for batch coordination, release, and product quality improvement.
  • Generate and maintain comprehensive project documentation, including status reports, timelines, and compliance records.

Qualifications

  • Bachelor's degree in a scientific or related field; advanced degree or relevant industry experience preferred.
  • Proven project leadership experience in regulated industries such as pharmaceuticals, biotech, medical devices, or related fields.
  • Strong background in operational QA, production engineering, or similar roles within the medical device or pharmaceutical industry, with additional experience in supply chain, manufacturing, or production coordination considered a plus.
  • Extensive knowledge of medical device regulations, GMP, quality systems, release processes, deviation management, and production workflows.
  • Experience working with customers or acting as a liaison to ensure clear communication and alignment on project goals and deliverables.
  • Demonstrated ability to manage multiple stakeholders and work cross-functionally.
  • Strong organizational, leadership, and project management skills.
  • Excellent communication and problem-solving abilities.


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