Job Details. Job Description. We are seeking an experienced CMC Project Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards. The ideal candidate possesses broad expertise in drug...
Job Details. Regulatory Affairs Specialist (Small Molecule IND, NDA, Module 3). Job Summary. This critical role demands extensive hands-on expertise in modifying regulatory strategies, authoring scientifically robust Chemistry, Manufacturing, and Controls (CMC) documentation within Module 3 of the eCTD, and managing submissions for Investigational New Drug (IND) and New Drug Applications (NDA) specifically for small molecule drugs. Key Responsibi...
Job Details. Primary Function of Position. The role would serve as the SME and advise on any challenges /issues that arise in formulation development, process optimization, and drug product manufacturing at external CDMOs to support non-clinical and clinical activities. The consultant will ensure scientific and technical standards are robust, data packages support regulatory filings, and quality controls are implemented in partnership with Qualit...
Job Details. Job Description: GMP Shipping and Logistics Specialist. Overview. Shipping and Logistics Specialist is responsible for coordinating and executing all domestic and international shipping activities for small molecule drug substances and drug product samples between our vendors, including Good Manufacturing Practice (GMP) samples. This role ensures strict adherence to all applicable regulatory requirements (e.g., FDA, EMA, IATA, DOT), ...
Job Details. Top Skills. Detailed Job description. Primary Function of Position. This position primary role is to work closely with the larger Customer Service / Field Service Organization Center of Excellence and with the internal IT Salesforce Architect to development and deploy new SFDC service-based solutions. Essential Job Duties. Implement new and enhance existing functionality including articulating requirements and translating them to eff...
Job Details. Position Summary. The ideal candidate will bring deep expertise in analytical method development and validation, CMC documentation, and management of analytical activities at contract development and manufacturing organizations (CDMOs) for both Drug Substance (DS) and Drug Product (DP) with significant experience in late-stage development (Phase 3 to Commercialization). You will serve as the primary technical liaison for our CDMO par...
Job Details. Job Description. We are seeking an experienced CMC Project Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards. The ideal candidate possesses broad expertise in drug...
Job Details. Regulatory Affairs Specialist (Small Molecule IND, NDA, Module 3). Job Summary. This critical role demands extensive hands-on expertise in modifying regulatory strategies, authoring scientifically robust Chemistry, Manufacturing, and Controls (CMC) documentation within Module 3 of the eCTD, and managing submissions for Investigational New Drug (IND) and New Drug Applications (NDA) specifically for small molecule drugs. Key Responsibi...
Job Details. Primary Function of Position. The role would serve as the SME and advise on any challenges /issues that arise in formulation development, process optimization, and drug product manufacturing at external CDMOs to support non-clinical and clinical activities. The consultant will ensure scientific and technical standards are robust, data packages support regulatory filings, and quality controls are implemented in partnership with Qualit...
Job Details. Job Description: GMP Shipping and Logistics Specialist. Overview. Shipping and Logistics Specialist is responsible for coordinating and executing all domestic and international shipping activities for small molecule drug substances and drug product samples between our vendors, including Good Manufacturing Practice (GMP) samples. This role ensures strict adherence to all applicable regulatory requirements (e.g., FDA, EMA, IATA, DOT), ...
Job Details. Top Skills. Detailed Job description. Primary Function of Position. This position primary role is to work closely with the larger Customer Service / Field Service Organization Center of Excellence and with the internal IT Salesforce Architect to development and deploy new SFDC service-based solutions. Essential Job Duties. Implement new and enhance existing functionality including articulating requirements and translating them to eff...
Job Details. Position Summary. The ideal candidate will bring deep expertise in analytical method development and validation, CMC documentation, and management of analytical activities at contract development and manufacturing organizations (CDMOs) for both Drug Substance (DS) and Drug Product (DP) with significant experience in late-stage development (Phase 3 to Commercialization). You will serve as the primary technical liaison for our CDMO par...
