Job Description
As Analytical Development Specialist – Assay Transfer & Validation, you play a key role in defining and executing assay transfers and validation strategies in compliance with GMP and current regulatory standards. You translate strategy into protocols, lead troubleshooting, and ensure the successful implementation of analytical methods in close collaboration with internal teams, customers, and partners.
Responsibilities
* Supervise and coordinate the full range of analytical tech transfer activities.
* Ensure tech transfers run smoothly, efficiently, and on time.
* Safeguard compliance with GMP guidelines and internal procedures throughout transfer and validation execution.
* Collaborate with multifunctional project teams to integrate analytical transfer into overall project plans and timelines.
* Lead the discussion, review, and alignment of strategies, protocols, results, and reports — internally, with customers, and with contract laboratories.
* Drive protocol writing, support execution, interpret and review data, and lead report generation.
* Provide troubleshooting oversight and technical expertise to resolve analytical challenges quickly.
* Support process comparability assessments during product lifecycle changes (e.g., scale-up, site changes, process updates).
* Monitor assay performance and take proactive action when needed.
* Address deviations, define and follow up CAPAs, and resolve analytical discrepancies impacting product release or stability.
* Mentor, support, and inspire junior colleagues to grow in their roles.
Vereisten
Qualifications
* Master or PhD in Life Sciences or equivalent through relevant experience.
* Proven experience in analytical tech transfer and assay validation in a GMP-regulated biopharma or biotech environment.
Competences
Technical
* Skilled in assay tech transfer and validation for biologics.
* Strong problem-solving and analytical skills.
* Experience with project management and cross-functional collaboration.
* Solid GMP knowledge and understanding of regulatory guidelines.
Soft Skills
* Thrives in the start-up dynamics of simAbs.
* Adaptable, hands-on, and pragmatic.
* Excellent communicator and relationship builder.
* Constructive, quality-focused, and proactive mindset.