MSAT AST Analytical Project Lead

Job title:

MSAT AST Analytical Project Lead

Company

House of Talents

Job description

IntroductieScience Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.We are very open and communicative go-getters who are keen on results and quality.To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.Work is important; however, we also attach great value to a healthy dose of fun@work! Triggered? Let’s meet!JobomschrijvingThe Analytical Project Lead is a member of the Analytical Science and Technology (AST) team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science, Analytics and Technology (MSAT) . The Recombinant Mammalian DS platform function within global MSAT is the owner of Life Cycle Management (LCM) of mammalian cell culture-based DS Processes within biologics manufacturing network.

• Lead the transfer and or co-validation of analytical methods in contract lab organizations (CLO) in close collaboration with internal experts on the analytical technologies.
• Act as primary contact for the CLO, gather information and data generated at the CLO’s and evaluate against available internal data for existing or new production processes.
• Plan the analytical project(s) in your responsibility, identify risks and report progress & risks to the analytical team and governance bodies.
• Maintain, adjust, and communicate documentation and knowledge.
• Write and review transfer/co-validation protocols and reports.
• Support dossier submission activities with regards to analytical aspects

Profiel

• Preferably PhD in Life Sciences or are equivalent through experience.
• Expertise in method transfer and validation in a GMP and non-GMP environment in accordance with current industry practices.
• Excellent analytical problem-solving mindset (escalate when needed) and can handle multiple tasks at the same time.
• Good technical writing skills and able to prepare protocols and reports. Able to draw up realistic project plan for method transfer/validation.
• Expertise in analytical technology (e.g. spectrophotometry, biological activity, potency binding ELISA, BIAcore, Octet, …) is a plus.
• Ability to work accurately while maintaining a strong focus on results and exhibiting a quality-oriented mindset.
• Ability to critically analyze data, draw scientifically sound conclusions, and formulate them correctly.
• Excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans.
• Team player and have good communication skills.
• Flexibility, stress-resistant, open to change & innovation, and used to working within deadlines.

AanbodWill you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues! We cannot wait to meet you! Fill in the form below and we will reach out to you soon.contract of indefenite duration, included:Company car + fuel cardHealth insuranceMeal vouchers of 8€ per day workedNet allowancesGroup insuranceSmartphone subscriptionEnd of year bonus (13th month)Eco vouchersSolliciteer nu

Expected salary

Location

Antwerpen

Job date

Wed, 06 Nov 2024 07:35:27 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.org) you saw this job posting.