Analytical Development Specialist – Assay Transfer & Validation

Diepenbeek - Belgium

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

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 impl...

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