Manufacturing Science, Analytics and Technology
Il y a 37 minutes
**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
**Job description**:
- Mission Description
The Manufacturing Science, Analytics and Technology Scientist (MSAT) 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) organization. The Recombinant Mammalian DS platform function within global MSAT is responsible for the Life Cycle Management of mammalian cell culture-based DS Processes within the biologics manufacturing network. The team delivers innovative, robust, and cost-effective next-generation processes, enables the launch of new products, and provides commercial manufacturing/Quality Control support. The function is responsible for tech transfer activities including fit-gap assessment, validation, dossier sections preparation, and PAI support to enable the launch of new and LCM products. The expansive portfolio covers multiple products, modalities, and expression systems within 12 internal and external global sites in the US and EU.
- Main Responsibilities
- Take full ownership of the planning, execution, reporting, and reviewing of analytical spectrophotometrical and biological activity assays (aPPT, chromogenic activity, enzyme kinetics).
- End-to-end method responsibility, starting with method handover up to method validation and transfer into a quality control organization.
- Identify improvements for existing methods to introduce new technology, increase method robustness, and reduce release cycle time.
- Provide investigational support for product and process, generate scientific/technical study protocols and reports, and assess the impact of significant deviations in analytical methods and production processes.
- Support analytical activities for product characterization, transfer, and process improvements for products in late development, next-generation, or commercial phase.
- Requirements
- Master’s or PhD in Life Sciences or equivalent through relevant experience.
- Prior hands-on experience with plate-based methods; experience with software SoftMax Pro is a plus.
- Willingness to work in the laboratory (75% worktime in the laboratory is expected).
- Good fundamental understanding of spectrophotometry and potency methods, with the ability to leverage this knowledge to accelerate projects and support troubleshooting.
- Good understanding of GMP and the manufacturing and testing of biologics.
- Quality-oriented mindset.
- Excellent analytical problem-solving skills, accuracy, and attention to detail.
- Familiarity with various statistical and data trending techniques; experience with Parallel Line Analysis (PLA) is a plus.
- Strong communication skills, with the ability to connect, discuss, and find compromises with people in other departments or sites.
- Comfortable speaking in public.
- Languages
- Dutch fluent
- English fluent in writing and speaking
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