DP MSAT Consultant
Start Date: November 2026
Duration: 12 Months (to November 2027)
Commitment: Approximately 25 hours per week
- Lyophilised vial (IV) drug product
- Pre-filled syringe (SC) drug product for subcutaneous administration
- Support drug product transfer activities from development into commercial manufacturing.
- Contribute to process scale-up and manufacturing readiness activities.
- Support execution and documentation of technical transfer programmes.
- Collaborate closely with Drug Product and Analytical functions to ensure alignment across the programme.
- Comparability Protocols and Reports
- Control Strategy documents
- Testing Strategy documents
- Elemental Impurities Risk Assessments
- Extractables & Leachables Risk Assessments
- Nitrosamine Risk Assessments
- Filter Validation Risk Assessments
- PPQ planning and readiness activities
- Process validation strategy
- Technical batch assessments
- Process risk management activities
- Process Change Gap Assessments
- Technology Transfer Master Plans
- Technical Batch Protocols and Reports
- PPQ Master Plans
- PPQ Protocols and Reports
- Process Risk Assessments
- Justification of Specifications documents
- Stability Protocols and Reports
- Extractables, Leachables and Toxicological Reports
- Significant experience within pharmaceutical Drug Product MSAT.
- Strong background in Technology Transfer and Scale-Up projects.
- Experience supporting PPQ / Process Validation activities.
- Hands-on involvement with lyophilised and/or sterile injectable products.
- Proven ability to author high-quality technical and CMC documentation.
- Experience working cross-functionally with:
- Drug Product Development
- Analytical Development
- MSAT
- Manufacturing
- Quality
If this opportunity sounds interesting, please click the relevant links to apply or feel free to share this advert with anyone in your network who you think would be suitable.
We look forward to hearing from you.
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