Assoc. Dir, External Manufacturing

Job Description

Required Skills and Experience: Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support. Strong problem-solving skills, root cause analysis and risk assessment/mitigation Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required. Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture. Must be able to work under own initiative, prioritise appropriately based on business need and work within tight deadlines. Flexibility and the ability to work independently as well as excellent organizational skills. Strong knowledge of quality systems, drug substance manufacturing and validation. Excellent command of English (both written and oral). Travel will be a requirement of this position at approximately 25% Preferred Experience and Skills: Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential. Lean Manufacturing / Six Sigma Experience Project management experience Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.