For one of our clients in Puurs, we are currently looking for a "Subject Matter Expert MSAT".
Job Description
The individual 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 troubleshooting and process improvements.
Responsibilities
- The individual will work in a diverse team and will be based in Puurs, Travel (20%) can be required
- The incumbent will demonstrate a proven operational expertise in formulation, preparation, lyophilization or aseptic filling processes in at least 1 manufacturing site.
- This position 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.
- Providing advanced technical subject matter expertise and issue resolution for major/complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner
- 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 .
- 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.
- Able to influence team members
- Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all stakeholders
Requirements
- Masters with minimum of 5+ years or Bachelors with minimum of 7+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
- A strong operational or engineering background in Drug Product operations is a requirement; experience as a Drug Product expert is definitely a plus
- Knowledge of cGMP requirements and compliance
- Excellent communication and technical writing skills; very good knowledge of English required
- Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
- Ability to think creatively and find innovative solutions is a plus
- Good communication and project management skills are needed
Benefits
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16868
