MSAT Subject Matter Expert

Contenido de trabajo

Organization

MSAT EU team is a very enthousiastic team of experts that give drug product support to all European Pfizer Sites and Contract Manufacturers during the entire life cycle of the product from R&D, clinical to commercial production.

You will play an important role in insuring that processes are robust and make sure that products on the market, stay on the market! You can work in an international environment and will be able to broaden your network and build on your technical knowlegde of making Sterile Injectables.

You will be part of a very dynamic, motivated and inclusive team!

Role summary

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.

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.

Role responsibilities

Technical

• 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 .
  

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
  

Qualifications

• Masters with minimum of 7+ years or Bachelors with minimum of 10+ 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
• Knowledge of cGMP requirements and compliance
• Excellent communication and technical writing skills
• 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
• Being based at DP manufacturing site is a plus
• Ability to participate in production floor activities when needed
• This position requires up to 20% of international travel within Europe.
  

Offer

• Permanent contract with numerous fringe benefits
• A culture of entrepreneurship and innovation
• Largest production and packaging site in Europe within the Pfizer network
• High investment rhythm
• High-tech environment
  

De Pfizer site in Puurs is één van de grootste productie- en verpakkingssites van Pfizer wereldwijd, gespecialiseerd in aseptische productie en verpakking. Jaarlijks worden in Puurs meer dan 400 miljoen doses injecteerbare vaccins en medicijnen geproduceerd. Deze zijn ter plaatse verpakt in ampullen, flacons, plastic flessen, spuiten en patronen voor pennen.

De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patiënten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo’s.

Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie.

Engineering