Jai Yadlapalli

About Jai Yadlapalli

Accomplished pharmaceutical team lead with strong transferable management skills as evidenced by 9 plus years industrial experience in managing multidisciplinary research projects in the analytical method development/validation of several API\'S and finished products (both NCE’s and Generics including ADC’s and polymers) with successful submission to FDA, EMA, MHRA, ANVISA for both NDA and ANDA approvals. Successful project manager resulting in the completion of 5 complex projects during 4 years of Ph.D. program and holds huge reputation in scientific community through 14 publications, including 8 first author manuscripts and over 180 citations. Experienced trainer and learner (9+ years experience) with expertise in areas of neuro pharmacology, analytical chemistry, regulatory affairs as evidenced by successful training of 3 scientists and 4 graduate students in complex data collection and analysis. I have the ability to contribute or synergize in an interdisciplinary team setting with strong analytical and technical skills, having worked closely with 4+ cross-functional teams. Excellent relationship builder, problem solver and conflict resolver as demonstrated by the expertise in phase appropriate analytical method development for complicated generic products, new chemical entities, dissecting mechanism of action of an opioid for treatment of chronic diabetic neuropathy, garnering interest in phase I clinical trials,>10 poster presentations in international and national conferences. Interested in Analytical Sciences, Regulatory Affairs, Project Management and Quality compliance jobs in Biotechnology, FDA and Pharmaceutical companies.| Analytical Chemistry | Regulatory Affairs | Quality compliance| Small and large molecules | Project Manager | Phase appropriate analytical methods| Team lead | Scientific Affairs | NCE’s and Generics | API and Finished product | ADC’s and linkers | Polymers |

Experience

1. Associate Director, Cmc Analytical

   Syndax Pharmaceuticals

   Jul 2024 — Present · NY, US

   Led and supported analytical and QC activities across early- and late-phase oncology programs, with a strong focus on oversight of third-party laboratories and ensuring high standards of data integrity, compliance, and collaboration across CMC functions.• Oversaw analytical and QC data generated at external contract labs to support the advancement of a rapidly expanding oncology pipeline.• Provided quality oversight of GMP analytical activities at contract service providers, ensuring data accuracy, completeness, and regulatory compliance.• Reviewed analytical data from release and stability testing, including compendial and non-compendial methods, for a variety of dosage forms (oral solutions, capsules, tablets).• Managed qualification, shipping, and documentation (COAs) for reference standards used in early and late development phases.• Led the planning and execution of stability studies, including sample pull schedules, protocol/report reviews, raw data assessments, and statistical data trending.• Coordinated cross-functional activities with Quality Assurance, Regulatory Affairs, CDMOs, and Product/Process Development teams to ensure program alignment and execution.• Oversaw method development activities at external labs, including qualifications, validations, transfers, and investigations (OOS/OOT).• Contributed to regulatory submissions (INDs, IMPDs, NDAs), authoring and reviewing CMC Module 3 content for both drug substance and drug product.• Authored and reviewed specifications, justifications, and shelf-life extension reports for early- and late-phase programs.• Identified process gaps and implemented improvements to enhance data review efficiency.• Actively contributed to lifecycle management strategies from a CMC analytical perspective.

Education

• UAMS - University of Arkansas for Medical Sciences

  Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences

  2011 — 2015

• Eastern Michigan University

  MS, Clinical Research and Industrial Drug Development

  2009 — 2011

• Andhra University

  Bachelor of Pharmacy, Pharmaceutical Sciences

  2005 — 2009