Process Safety Specialist

1 month ago

Eastern England, United Kingdom Asymchem Group Full time

Company Overview:

Founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization. Asymchem was thrilled to recently announce the acquisition of R&D laboratories and small molecule API pilot plant at Discovery Park, Sandwich, UK, establishing our first manufacturing facility in Europe and expanding our capabilities to meet the needs of global clients. It is envisaged that the Sandwich facility will continue to flourish and act as the flagship site for European R&D capabilities. We are looking to recruit into key roles and see this as a fantastic opportunity to join a collaborative dynamic team and help shape the operations and future of this site.

Job Overview:

Working within collaborative teams at our new Sandwich laboratories, you will play a pivotal role in ensuring the safety of processes intended for Manufacture of APIs, and their intermediates, on laboratory, pilot plant and commercial manufacturing scales.

Role & Responsibilities:

  • Application of Process Safety workflows in partnership with project teams during laboratory scale-up and scale-up into pilot plant facilities, ensuring appropriate recommendations are made.
  • Design, execute and interpret complex laboratory experiments to accurately assess the safety of starting materials, intermediates, reagents waste streams and chemical reactions prior to scale-up and help implement suitable mitigation measures.
  • Formulate clear, concise recommendations based on process safety testing results in detailed reports and oral representation.
  • Lead / contribute to the evaluation of novel technologies and techniques to maintain world class process safety testing capabilities.
  • Maintain laboratory operations, proactively work with vendors / internal engineers to maintain equipment to a high standard and ensure optimal performance to mitigate down time.
  • Identify initiatives to enhance process safety workflows and technology to improve process safety testing efficiency.
  • Ensure good collaboration and proactive engagement with external bodies where necessary, to enhance knowledge within the group. Establish networks and interfaces across the pharma/CDMO space and academia.
  • Collaborate with stakeholders to forecast short, mid and long term forecasts for resource needs to ensure customers needs are met.
  • Acts as a resource across the process safety network to give expert opinion and alternative insights on the interpretation of data to ensure effective assessment of chemical reaction hazards.
  • Work with external testing houses to identify and coordinate safety testing where required to generate data outside of internal capabilities and foster effective relationships.
  • Deliver process safety testing training to new starters and develop new training materials where required as the process safety function evolves.

Experience Requirements - Knowledge, Skills, & Abilities (KSAs):

  • BS/MS in chemistry or chemical engineering with a minimum 10 years (relevant API) experience in small molecule development.
  • Awareness and expertise in the various elements and concepts of process safety testing and inherently safer process design.
  • Hands-on experience operating and data interpretation from the following state of the art process safety testing equipment:
  • Differential Scanning Calorimetry, Thermal Screening Unit (or similar), Accelerating Rate Calorimetry, Mettler Toledo RC1.
  • Experience in writing process safety testing documents to support the safe scale-up of processes during laboratory studies and tech transfer to pilot plant and commercial facilities. Active participant in process hazard analyses.
  • Proven track record in mentoring junior colleagues.
  • Ability to perform complex tasks such as handling large amounts of data and performing mathematical calculations.

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