Chemical API Subject Matter Expert

4 weken geleden

Amsterdam, Nederland PM Group Voltijd
Overview

The Role

We have an exciting opportunity for a Chemical API SME to join our team.The role is to work as a Subject Matter Expert providing technical leadership on Chemical API. As a member of the global SME Group the person employed can be located in one of the PM Group offices in Europe. We work a hybrid work model while the role will require travel to project meetings/workshops as required.

Who we are

PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.


Responsibilities

  • To be a technology leader in nominated area(s) which includes:
    • Being current in technical and subject knowledge
    • Being aware of upcoming technology changes, developments, innovations
    • Writing papers, presenting at industry conferences
    • Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
    • Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
  • To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID’s and layout philosophies, early phase project reports
  • To technically assist project teams as required.
  • To undertake Peer Reviews of work performed by other companies.
  • To perform in appropriate SMEs reviews of client sites.
  • To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company
  • To participate and/or chair technical design reviews as appropriate.
  • To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
  • To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities.
  • To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
  • To be 80% bookable.
  • Travel to Project meetings /workshops as required
  • Other special projects as assigned

Specific Knowledge Areas to be covered by the Role include

  • Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs
  • Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending
  • Principles of facility layout such as:
    • Layout adjacencies
    • Stack-up
    • Segregation approaches
  • Aspects related to technologies such as:
    • Batch, semi-continuous and continuous processing
    • Solvent and reagent handling
    • Materials handling
    • Cleaning technologies
    • Solid, liquid and gaseous waste handling and treatment
    • Automation
    • Utility generation and distribution
  • Aspects related to project delivery such as:
    • Basis of design
    • Safety framework including relief systems, ATEX, and containment
    • Simulation tools
    • Tech Transfer
    • Bid analysis
    • Supplier interfacing
    • Commissioning and Qualification
  • Aspects related to facility operations such as:
    • Operating philosophies
    • GMP Regulatory framework

Qualifications

  • Bachelor’s degree; Masters preferred
  • 15 years + of appropriate experience around Chemical API facilities and operations
  • A history of wider industry engagement with institutions such as the ICHEME (or equivalent) and an awareness of key industry technology initiatives and direction
  • Excellent knowledge relating to area of speciality
  • Direct experience working within capital projects and delivery related to process facility design and construction
  • Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Heath, Safety & Well-being Report 2022.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

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