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Process Safety Engineer
2 months ago
Company Overview:
Asymchem Group, established in 1999, is a prominent global Contract Development and Manufacturing Organization (CDMO) that specializes in drug research and manufacturing for leading pharmaceutical and biotech enterprises. Our commitment is to foster smarter, more sustainable, and cost-efficient manufacturing processes that support clinical research and product commercialization. We are excited to expand our capabilities with the recent acquisition of R&D laboratories and a small molecule API pilot plant, enhancing our service offerings to meet the diverse needs of our international clientele.
Job Overview:
In this role, you will be an integral part of our collaborative teams at the Sandwich laboratories, focusing on ensuring the safety of processes involved in the manufacture of Active Pharmaceutical Ingredients (APIs) and their intermediates across various scales, including laboratory, pilot plant, and commercial manufacturing.
Key Responsibilities:
- Implement Process Safety protocols in collaboration with project teams during laboratory scale-up and transition to pilot plant operations, ensuring that suitable recommendations are provided.
- Design, conduct, and analyze intricate laboratory experiments to thoroughly evaluate the safety of starting materials, intermediates, reagents, waste streams, and chemical reactions prior to scale-up, while helping to establish effective mitigation strategies.
- Provide clear and concise recommendations based on process safety testing outcomes in comprehensive reports and presentations.
- Lead or contribute to the assessment of innovative technologies and methodologies to uphold top-tier process safety testing capabilities.
- Oversee laboratory operations, working proactively with vendors and internal engineers to maintain equipment to the highest standards, ensuring optimal performance and minimizing downtime.
- Identify opportunities to enhance process safety workflows and technologies to boost the efficiency of process safety testing.
- Foster collaboration and proactive engagement with external organizations as necessary to enhance knowledge within the team, establishing networks across the pharmaceutical/CDMO sector and academia.
- Collaborate with stakeholders to project short, medium, and long-term resource requirements to ensure customer satisfaction.
- Serve as a resource within the process safety network, providing expert insights and alternative perspectives on data interpretation to ensure effective assessment of chemical reaction hazards.
- Coordinate with external testing facilities to identify and manage safety testing as needed, cultivating effective partnerships.
- Deliver process safety training to new employees and develop new training materials as the process safety function evolves.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
- Bachelor's or Master's degree in chemistry or chemical engineering with a minimum of 10 years of relevant experience in small molecule development.
- In-depth knowledge and expertise in various aspects of process safety testing and inherently safer process design.
- Hands-on experience with advanced process safety testing equipment, including Differential Scanning Calorimetry, Thermal Screening Units, Accelerating Rate Calorimetry, and Mettler Toledo RC1.
- Proven experience in drafting process safety testing documentation to support the safe scale-up of processes during laboratory studies and technology transfer to pilot and commercial facilities, with active participation in process hazard analyses.
- Demonstrated success in mentoring junior team members.
- Capability to manage complex tasks, including handling extensive data sets and performing mathematical calculations.
