MSAT Project Lead
6 days ago
Job Title: MSAT Project Lead
We are seeking an experienced MSAT Project Lead to oversee tech transfers of production processes for vital medicines (VMs). The ideal candidate will work with various departments and stakeholders to address manufacturing, quality, and testing challenges.
About the Role:
- Represent the MSAT department in cross-functional projects and manage technical aspects of portfolio projects.
- Lead technical communication with manufacturing sites and review proposed technical projects.
- Provide technical/scientific advice to procurement and prepare purchase orders.
- Plan and execute site-to-site manufacturing transfers, ensuring compliance and timely registration.
- Offer scientific and technical support to internal and external stakeholders to resolve technical, compliance, and quality issues.
- Optimize product manufacturing processes at CMO sites.
- Support regulatory stakeholders in addressing batch failures and variations.
- Review and approve technical documentation, including product quality documents and risk assessments.
- Conduct technical reviews and due diligence for potential acquisition initiatives.
- Maintain and update internal documentation and follow safe procedures.
- Raise Change Control Requests and ensure adherence to SOPs and in-house procedures.
Key Requirements:
- Degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, or Chemistry.
- Project management certification (Prince2, PMP, or equivalent).
- Experience in site tech transfer, pharmaceutical manufacturing, QC testing, and packaging.
- Knowledge of biologics (essential), small molecules would be desirable.
- Proven project management and execution skills, including successful site tech transfers.
- Global exposure to pharmaceutical manufacturing, registration, and distribution.
- Agile thinker with excellent organizational and time management skills.
- Strong communication and interpersonal skills.
- Ability to work collaboratively in a team environment.
- Demonstrates a growth mindset, integrity, and high ethical standards.
- Results-oriented and accountable for actions.
- Problem-solving skills with the ability to assimilate data from various scientific areas.
Salary: £70,000 - £90,000 per annum, depending on experience. We offer a competitive salary and benefits package, including access to training and development opportunities.
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