Darrius Joiner

About Darrius Joiner

Ensuring method validation practices and method transfers are consistent with current regulatory expectations and compendial monographs (including evaluating existing method validation data and acting to facilitate updating packages as needed). Providing laboratory support (e.g. method development, validation and execution for non-routine needs to support manufacturing process initiatives on a global basis. Develop and implement improved laboratory assays and processes on a global basis (including variability reduction, method optimization, method remediation and new method development). Transferring analytical methods to various sites (local, global and third party). Interacting with customers from a technical perspective. Directing laboratory activities and interpreting analytical data. Coordinating projects with customers in manufacturing technical services, analytical development and global quality control laboratories. Responsible for procuring equipment and resources for projects, creating instrumental analysis methods, and managing project timelines. Provide training and mentoring of analysts. Author and executing scientific studies, protocols, and technical documents. Strong communication and leadership skills. Organize and research developmental projects, analysis and statistical summary of analytical data, operation of chromatographic and spectroscopic instrumentation. Strong analytical instrumentation and troubleshooting background (HPLC, GC, CE, UV/Vis, FT-IR etc.). Experience with various compendia and analytical techniques (stability testing, content uniformity testing, dissolution testing, cleaning validation etc.). Experience with small and large molecules in addition to various types sample matrices (i.e. tablets, capsules, liquid formulations, lyophilized products, insulins, proteins, fermentation products etc.). Strong compliance background, majority of career involved engaging cGMP laboratory customers.

Experience

1. Principal Research Scientist - Synthetic Molecule Design & Development (Smdd)

   Eli Lilly and Company

   Mar 2025 — Present · Indianapolis, IN, US

   Member of a cross functional team of analytical chemists, organic chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms (e.g. small molecule, peptides, and oligonucleotides). Collaborating with scientists across Eli Lilly’s Development and Manufacturing organizations to develop and implement robust analytical methods and control strategies. Evaluating and/or deploying new analytical technologies/methods to advance Lilly\'s current analytical capabilities.We\'re a medicine company turning science into healing to make life better for people around the world. It all started nearly 150 years ago with a clear vision from founder Colonel Eli Lilly:\"Take what you find here and make it better and better.\" Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing science to solve some of the world\'s most significant health challenges.

Education

• Indiana University

  B.S

  1987 — 1992

• Indiana University Bloomington

  B.S.

  1987 — 1992

Skills

• Formulation
• 21 Cfr Part 11
• Validation
• Mass Spectrometry
• Computer System Validation
• Method Development
• Pharmaceutical Industry
• Sop
• Fda
• Wet Chemistry
• Laboratory
• Drug Development
• Biotechnology
• Biopharmaceuticals
• Dissolution Testing
• Capa
• Tlc
• Uv/Vis
• Assay Development
• Ind
• Regulatory Affairs
• Purification
• Organic Chemistry
• Spectroscopy
• Quality Control
• Glp
• Usp
• Gmp
• Chromatography
• Protein Chemistry
• Cleaning Validation
• Change Control
• Technology Transfer
• Life Sciences
• Dissolution
• Gas Chromatography
• Analytical Chemistry
• Gxp
• Aseptic Processing
• Chemistry