Advisor - Chemical Hazards Laboratory SMDD Foundry Readiness

Eli Lilly and Company•Indianapolis, IN

3d•Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of active pharmaceutical ingredients and formulated drug products from pre-clinical phases through commercialization of drug substances and drug products for small molecules, synthetic oligonucleotides, and synthetic peptides. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed up testing of the clinical hypothesis and overall drug development. SMDD tackles this diversity of responsibilities by recognizing that an even greater diversity of talents and cultures is necessary to deliver the next generation of life changing medicines to patients. Chemical Hazards Lab (CHL) The Chemical Hazards Lab (CHL) within the Process Design and Development division of Synthetic Molecule Design and Development (SMDD) at Eli Lilly and Company provides thermal and dust hazard analyses for products and processes using rigorous experimental design and execution in conjunction with established methods for assessing thermal stability. The majority of the CHLs activity is related to small molecule development assets, although consultation and services are also provided to other Lilly Divisions (e.g., Manufacturing, pilot-plants, kilo-labs, Biologics R&D, Discovery Chemistry, and External Manufacturing). The CHL workflow includes internal experimental activities (calorimetry, SADT Determination, flash point determination, Fall hammer tests), oversight of outsourced thermal testing activities (Dust explosivity, Vent Sizing, UN explosivity), and collaborating with SMDD scientists to design, develop, and execute inherently safe processes with Lilly Manufacturing or in our third party supplier network.

Requirements

PhD in Chemistry or Chemical Engineering or related discipline
MS in Chemistry or Chemical Engineering or related discipline with minimum of 8+ years of experience in process safety and lab experimentation
BS in Chemistry or Chemical Engineering or related discipline with minimum of 12+ years of experience in process safety and lab experimentation

Nice To Haves

Experience in synthetic molecule drug substance process development and related safety assessments.
Reaction Calorimeter, Differential Scanning Calorimeter, Accelerating Rate Calorimeter, Differential Accelerating Rate Calorimeter and micro calorimeters, HPLC, GC and Optimelt.
Knowledge and experience for data interpretation and analysis of experimental results as applied to process safety assessments, including concepts of adiabatic temperature rise, adiabatic time to maximum rate, Stoessel reactivity classes, Semonov Diagrams and critical temperatures.
Basic knowledge of dust explosivity (Kst and Pmax), vent sizing calculations, electrostatics and other tests/test methods applicable to commercial scale process safety analysis and shipping practices.
Knowledge of industry best practices for process safety, process safety test analysis, and chemical reactivity analysis
Experience with commercial manufacturing scale process design and processing equipment, including scale-up and troubleshooting.
Experience with commercial scale process controls and basic knowledge of process control design
Experience with inherently safer chemical process design
Knowledge of chemical reactivity and industrial chemical reactivity accidents
Knowledge of Organic Chemistry and/or Chemical Engineering fundamentals, including reaction mechanisms, kinetics, and thermodynamics.
Understanding and implementation of first principles modeling and use of modeling tools such as DynoChem, Aspen Properties, gPROMS Process Builder, CHETAH and AKTS software
Knowledge of modeling critical scale-up parameters to predict potential hazardous behavior on scale-upsKnowledge of model decomposition kinetics through application of Model-Free kinetics and other techniques as appropriate.
theoretical calculations as necessary to estimate heat of decomposition, heat of reaction, flammability parameters, and other difficult to measure quantities.
Oral and written communication skills
Organizational and interpersonal skills
Leadership and team work skills
Coaching/mentoring skills

Responsibilities

Perform and/or oversee the design and implementation of reaction calorimetry, thermal stability, flammability, explosivity, and chemical compatibility tests.
Interpret experimental data and provide specific guidance to scientists to eliminate or minimize/mitigate risks due to detected thermal hazards.
Serve as a champion for good process safety practices through specific proactive guidance to development teams.
Participate in root-cause experimentation and analysis to determine if incidents were caused by reactive chemical hazards.
Coordinate outsourced thermal hazards testing for Lilly Development Projects
Perform process safety literature reviews
Ensure creation of accurate test reports and timely delivery of results/interpretation for all thermal hazards testing.
Author and/or Review Process Safety Reports containing process safety testing, compound test analysis and synthetic route safety analysis for projects reaching appropriate milestones or as requested; ensure timely delivery of reports to project teams, Lilly manufacturing, and third party organizations as appropriate.
Review SURFs (Scale-Up Review Forms) prior to scale-up execution for the Discovery Chemistry Synthesis Group (DCSG) and SMDD as needed.
Provide process safety training and consultation for Lilly employees and our network partners.
Review and assess process safety needs for new or additional test capabilities
Research and develop new technology for applicability to process development
Review proposed synthetic routes and provide process safety input to aid in prioritization of route design efforts.
Complete risk assessments for API synthetic route development at all stages (Route Design, Route Definition, Route Optimization) of development
Collaborate with Development Teams to implement inherently safer chemical design changes or safety-mitigating process improvements
Document experiments in electronic lab notebook.
Author internal technical reports for broad-based safety topics.
Maintain current working knowledge of process safety/dangerous good transportation laws as they relate to process safety, chemical reactivity and thermal stability.
Develop skills and internal contacts to become a trusted expert on chemical process safety, inherently safer chemical process design, and chemical reactivity matters within Lilly
Act as technical mentor for technical staff across Lilly functions
Publish safety related articles in applicable journals
Attend and present at process safety-related conferences.
Develop and enhance Lillys process safety reputation by representing Lilly as contributing member or leader in local, national or global process safety professional organizations

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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