Stability Project Manager
Il y a 7 mois
**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**:
We are seeking a Stability Project Manager to play a crucial role in the Analytical Development department. The team focuses on achieving a comprehensive scientific understanding of the stability behavior of Drug Substance (DS) and Drug Product (DP) for small molecules and new modalities. Responsibilities include designing, performing, and interpreting customized stability studies, as well as (non-)clinical introduction and production/characterization support of the DS and DP from phase I through to registration.
**Your Responsibilities**: As the Stability Project Manager, you will be assigned to various development projects, managing all related CRS aspects and serving as the point person on stability and release issues for the assigned development projects. Your main responsibilities will include:
- Designing and coordinating experiments to assess the chemical and physical stability of new products
- Working closely with internal and external laboratories to ensure successful execution
- Providing insight into long-term drug stability using predictive models and traditional stability tests
- Performing data trend analysis
- Representing the group on cross-functional analytical teams
- Communicating and reporting stability results
- Coordinating global projects
- Managing analytical investigations and discrepancies
- Ensuring compliance with relevant regulations, GMP, and safety
**About You**:
- Master's degree in chemistry, bioengineering, or pharmaceutical sciences, or equivalent experience
- In-depth knowledge and experience with analytical techniques for drug characterization
- Strong planning, organizational, and project management skills
- Excellent communication, team presentation, and data analysis skills
- Flexibility, adaptability, and practical industry experience
- Knowledge of GMP regulations
- Fluency in English (knowledge of Dutch is a plus)
- What You Can Expect
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