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Msat Subject Matter Expert

Il y a 5 mois


Puurs, Belgique Pauwels Consulting Temps plein

**Job description**:

- We are currently looking for an MSAT expert in drug development / medical devices.
- The consultant selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing trouble shooting and process improvements. The consultant will demonstrate a proven operational expertise in formulation, preparation, lyophilization or aseptic filling processes in at least 1 manufacturing site. This project requires behaviors exhibited through effective and direct communication skills, bold leadership and facilitation, and an effortless ability to influence and integrate various colleagues from all levels of the organization.

**Scope of work**:
Technical
- Participating in the Co-Development process, particularly in Late-Stage Development/Phase 3 Clinical Supply to commercialization and continued product support
- Applies technical knowledge and skills to achieve goals at the business unit level
- Preparing, reviewing, and approving documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
- Collaborating with wet and analytical labs (e.g., Experimental Pilot Plant in Puurs) to execute exploratory or feasibility studies.

Managerial
- Contributing to and occasionally leading complex projects
- Maintaining monthly project updates in project tracking system and other methods, as requested
- Strong influencing skills and ability to work in a matrix organization to deliver results
- Comfortable with multifunctional and multi-cultural environments.

Interpersonal Effectiveness
- Highly respected colleague; able to influence team members across PGS and other business units
- Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all stakeholders
- Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, PD&S, PharmSci, VRU, GCMC
- Attending project meetings, presenting data, and supporting senior management team including travel, when needed

Approach / Mindset
- Recognizes cross-functional impact in all decision-making; decisions may impact business unit goals. Proactively reaches out to external stakeholder groups to gain alignment on cross-functional issues
- Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving
- Knows when to report or escalate risks and issues to leadership and provides alternative approaches/solutions to mitigate these risks/issues
- Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance
- Embraces Pfizer Purpose: Breakthroughs that change patients lives through the incorporation of the Bold Moves and Values and Behavior

**Benefits**:

- Uitdagende projecten in lijn met jouw interesses en talenten
- Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
- Mogelijkheid tot het volgen van extra opleidingen
- Inspirerende netwerkevents en legendarische afterwork drinks
- Sterk netwerk van toonaangevende klanten
- Expertise binnen IT, Engineering en Life Sciences
- Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
- Un package salarial attractif avec de nombreux avantages extra-légaux
- Un suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en poste
- La possibilité de suivre des formations
- Divers événement vous permettant de développer votre réseau et des afterwork drinks légendaires
- Un réseau puissant de clients, leaders dans leur domaine
- Une expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vie
- Un tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors

**Have you got what it takes?**:
**Qualifications**
- Masters with minimum of 7+ years or Bachelors with minimum of