Knowledge, Skills, or Abilities: Ability to adapt communication style to differing audiences and advise others on complex matters.
Ability to navigate through crucial conversations.
Effective communication, both written and oral
Ability to generate mechanistic and theoretical hypotheses.
Advanced project management skills
Ability to effectively present information to others
Strong strategic thinking skills
Minimum Requirements:- Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., manufacturing); OR
Master's degree with 6 years of experience; OR
PhD with 4 years of experience
Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
Preferred Requirements: Prior Drug Product manufacturing experience
Experience working in a cGMP environment
Experience supporting or writing portions of regulatory findings
Experience qualifying automatic visual inspection equipment
Experience in CCIT qualification
Experience with filling isolators
Experience leading aseptic process simulations
Experience authoring risk assessments and manufacturing control strategies