Join a trailblazing biotech on the cutting edge of science and technology.
Proclinical is seeking a Senior MSAT Scientist to join a dynamic team in Surrey, UK. In this role, you will leverage your scientific expertise to support the technical transfer of pharmaceutical manufacturing processes. This includes working with Contract Manufacturing Organizations (CMOs) to optimize production, address quality challenges, and ensure the continuous supply of vital medicines. You will play a key role in improving manufacturing efficiency, supporting product growth, and contributing to regulatory submissions.
This position offers a global scope, with opportunities for collaboration across cross-functional teams and occasional travel to CMOs. If you are passionate about driving innovation in pharmaceutical manufacturing and thrive in a collaborative environment, this role is for you.
Responsibilities:
- Support the initiation, planning, and execution of site-to-site manufacturing process transfers by managing technical documentation, data collection, and internal communication.
- Collaborate with senior team members to compile technical data for regulatory submissions related to new site registrations.
- Represent the MSAT department in cross-functional project meetings, providing technical insights alongside Supply Chain, Regulatory, and Commercial teams.
- Prepare and organize technical documentation for internal and external manufacturing sites, ensuring clear communication of technical requirements.
- Assist in creating purchase orders (POs) and tracking project budgets, including CAPEX and CoGs, to ensure alignment with approved cost estimates.
- Address technical and quality-related issues by coordinating with internal experts and external partners, such as CMOs and CROs.
- Review and organize technical documents, including product quality reports, certificates of analysis, stability reports, and batch records, ensuring compliance with product registrations.
- Support technical due diligence activities for potential product acquisitions by gathering background information and documentation.
- Maintain accurate and up-to-date documentation in shared systems, adhering to internal procedures for file storage and data handling.
- Raise and track Change Control Requests (CCRs) and ensure compliance with SOPs and in-house procedures.
Key Skills and Requirements:
- Degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, or Chemistry.
- Demonstrated experience in site technical transfers, including exposure to pharmaceutical manufacturing, QC testing, and packaging.
- Familiarity with small molecule formats such as steriles, capsules, creams, gels, ointments, and solid dose.
- Proven ability to manage and execute projects successfully, including site tech transfers.
- Global experience in manufacturing, registering, and distributing pharmaceuticals.
- Project management certification (e.g., Prince2, PMP) is advantageous.
- Strong organizational and time management skills with attention to detail.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a team environment and adapt to high-speed changes.
- Problem-solving mindset with the ability to assimilate data from diverse scientific areas.
- Commitment to integrity, ethical standards, and accountability.
If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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