Overview The Role We have an exciting opportunity for a Chemical API SME to join our 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.
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.
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 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.
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.
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.
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.