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Mixed Modality, Oligonucleotide Scientist
Eli Lilly and Company. Evaluate and facilitate transfer of oligonucleotide manufacturing processes from development laboratories to pilot plant operations, including kilo-scale and isolator production environments .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in oligonucleotide manufacturing processes, including solid-phase synthesis, chromatography, and cGMP compliance, while effectively leading projects and mentoring team members in a fast-paced environment.
Highest-signal resume keywords
Oligonucleotide Process DevelopmentCGMP ManufacturingAnalytical Techniques (HPLC/UPLC, LC-MS, GC)Process Scale-Up and TroubleshootingTechnical Document Authoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Oligonucleotide SynthesisPreparative ChromatographyTFF (Tangential Flow Filtration)LyophilizationData AnalysisRoot Cause AnalysisBatch Record CreationProcess QuantificationMass Balance AcquisitionAseptic Processing
Soft Skills
Excellent Communication SkillsProject CoordinationTime ManagementMentoringProblem-Solving
Tools & Technologies
Larger-Sized ReactorsPreparative ColumnsAnalytical Equipment
Industry Keywords
Biopharmaceutical ManufacturingTechnical ServicesProcess EngineeringClinical Trial SupplySafety Evaluation
About the role
Key responsibilities & impact- Evaluate and facilitate transfer of oligonucleotide manufacturing processes from development laboratories to pilot plant operations, including kilo-scale and isolator production environments
- Enable transition to early-phase cGMP manufacturing of gram-to-kilogram quantities of API for clinical trial supply
- Oversee transfer of new oligonucleotide processes from development to manufacturing
- Ensure scalability and process fit to the plant
- Troubleshoot production issues and implement new technologies or procedures
- Assess and scale up synthesis and purification methods
- Perform oligonucleotide procedures including solid-phase synthesis, preparative chromatography, TFF, and lyophilization
- Evaluate safety of incoming procedures with safety and process engineering groups
- Analyze analytical data to make fact-based decisions
- Summarize and present chemistry and technical challenges
- Lead familiarization executions to ensure plant readiness for synthesis, cleavage, purification, TFF, and lyophilization
- Perform use-tests of key in-process materials and document Definitive Lab Trials
- Author and review technical documents, including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports
- Lead process-related investigations, assess deviations, and support CAPAs
- Collaborate with CMC, Product R&D, Manufacturing, and Quality teams
- Provide on-floor support for critical operations
- Train and mentor junior scientists and technicians in PTE activities
Requirements
What you’ll need- B.S. or M.S. in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or a related discipline
- B.S. with 10+ years or M.S. with 7+ years of experience in Oligonucleotide Product/Process Development, Manufacturing Technical Services, or related functional roles
- Authorized to work in the United States on a full-time basis
- Strong knowledge of oligonucleotide processes, including synthesis, cleavage and deprotection, chromatography, conjugation, and aseptic processing
- Ability to analyze data, perform root cause analysis, and resolve complex technical challenges
- Understanding of biopharmaceutical manufacturing principles and cGMP requirements
- Experience leading small projects, coordinating activities, and managing timelines
- Experience with oligo synthesis and purification techniques used for developing and scaling-up process reactions
- Comfortable working with larger-sized reactors, preparative columns, TFF, and related equipment
- Experience creating batch records and conducting scale-up experiments
- Experience with analytical techniques including HPLC/UPLC, LC-MS, and GC
- Ability to perform process quantification and acquire mass balance for products and by-products
- Excellent written and verbal communication skills
- Ability to prioritize multiple activities and manage ambiguity
- Ability to work in manufacturing and laboratory environments
Benefits
Comp & perks- Company bonus depending on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities