Role Summary
Project Manager for MSAT Packaging Operations, responsible for ensuring continuous improvement and compliance of processes and materials. Collaborate with cross-functional teams to drive projects that enhance efficiency, quality, and sustainability. Opportunity to grow expertise and lead impactful initiatives within a dynamic, regulated environment.
Responsibilities
- Lead technical projects supporting the qualification of primary packaging components for sterile products, ensuring alignment with standards.
- Develop and implement continuous improvement projects, including preparing business cases and managing budgets.
- Maintain and share process and product knowledge across manufacturing, quality, and regulatory teams.
- Prepare and manage risk assessments for incoming materials, identifying opportunities for improvement.
- Act as a key contact during internal and external audits, providing expertise on processes and materials.
- Ensure compliance with quality and regulatory requirements while driving operational excellence.
Qualifications
- BachelorβΓΓ΄s degree in a scientific or technical field (e.g., chemistry, bioengineering, life sciences).
- Project management experience
- Life Cycle management experience
- Primary packaging components for sterile products experience
- OR in lieu of Primary Packaging components of Sterile product experience, 5+ years of experience in biopharmaceutical manufacturing or related fields (e.g., QA, QC, regulatory affairs).
Preferred Qualifications
- Expertise in managing incoming materials within a pharmaceutical or biopharmaceutical setting.
- Experience with continuous improvement methodologies (e.g., Lean, Six Sigma).
- Strong problem-solving and decision-making skills.
- Ability to influence and collaborate across diverse teams and stakeholders.
- Familiarity with project management tools and processes.
- Proven experience in project management, including leading cross-functional teams.
- Strong understanding of compliance requirements in a regulated environment.
- Excellent communication skills, both written and verbal, in English.
- Ability to analyze data and manage complex projects effectively.