Analytical Development Specialist

simAbs; Diepenbeek; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A biotechnology company in Diepenbeek is looking for an Analytical-QC Expert Assay Transfer & Validation. In this critical role, you will supervise assay transfer activities, ensuring compliance with GMP regulations and collaborating with various teams. A Master's or PhD in Life Sciences and experience in analytical tech transfer are required. This position offers the opportunity to work in a dynamic startup environment and mentor junior colleagues.

Qualifications

• Master or PhD in Life sciences or equivalent experience.
• Proven track record in analytical tech transfer and assay validation in a regulated environment.

Responsabilités

• Supervise analytical tech transfer activities.
• Ensure compliance with GMP guidelines.
• Collaborate with project teams on plans and timelines.
• Lead discussions and align on tech transfer strategies.
• Provide troubleshooting oversight for analytical challenges.

Connaissances

Assay tech transfer

Problem-solving skills

Project management

Cross-functional teamwork

GMP knowledge

Adaptability

Communication skills

Formation

Master or PhD in Life Sciences

Description du poste

As Analytical-QC Expert Assay Transfer & Validation, you have the critical role to define, in compliance with current standards & regulations, assay transfers and their qualification/validation strategy. You will translate strategy into protocols and you are a strong troubleshooter to ensure successful assay implementation. You have the key responsibility to closely collaborate and partner with the customer.

In case of assay outsourcing to a 3rd party, you are also the one to manage that interface between simAbs and the contract laboratory.

You are the overall lead overseeing all the tech transfer aspects, including progress reporting as well as issue escalation with mitigation proposals to key stakeholders.

Responsibilities:

• Supervise and coordinate the full range of analytical tech transfer activities.
• Ensure tech transfers run smoothly, efficiently, successfully 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 tech transfer 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, minimizing budget and timeline impact.
• Support process comparability assessments during product lifecycle changes (e.g. scale-up, site changes, process updates).
• Monitor assay performance after successful implementation 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.

Qualification:

• Master or PhD in Life sciences or equivalent through relevant experience. Comprehensive knowledge in biotechnology or bio-pharmaceutical manufacturing and release; with proven track record in analytical tech transfer and assay validation in a regulated environment.

Competences:

Technical skills:

• Proficient in assay tech transfer and validation within biologics or bio-pharmaceutical space
• Strong problem-solving and analytical skills
• Experience with project management and the ability to manage multiple priorities
• Ability to work in cross-functional teams
• Skilled in GMP and good understanding of regulatory guidelines

Soft skills:

• Enjoying the start-up dynamics of simAbs
• Adaptability and agility: ability to embrace change
• Critical thinking and problem-solving skills
• Quality mindset
• Pragmatic & hands on mentality
• Good interpersonal skills – team player
• Relationship building capability
• Good Listening skills
• Excellent communication and presentation skills (both written and verbal).
• Positive and constructive attitude