Associate Director, Cleanroom Operations Lead

4 weeks ago

Summit, New Jersey, United States Caliber Sourcing Full time
Job Description

Bristol Myers Squibb is seeking a highly skilled and experienced Associate Director, Cleanroom Operations to lead our cleanroom operations team. As a key member of our team, you will be responsible for ensuring the smooth operation of our cleanroom facilities, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.

Key Responsibilities:
  • Lead a team of cleanroom operations specialists to ensure the efficient and effective operation of our cleanroom facilities.
  • Develop and implement strategies to improve cleanroom operations, including process improvements, training programs, and quality control initiatives.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
  • Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure consistency and quality in cleanroom operations.
  • Conduct regular safety audits and Gemba walks to identify and mitigate potential hazards.
  • Develop and implement training programs to ensure that team members have the necessary skills and knowledge to perform their jobs effectively.
  • Collaborate with the production scheduling team to ensure that production schedules are met and that resources are allocated effectively.
  • Develop and maintain relationships with key stakeholders, including suppliers, customers, and regulatory agencies.
Requirements:
  • Bachelor's degree in a relevant field, such as supply chain, engineering, or life sciences.
  • 9+ years of relevant work experience, preferably in a regulated pharmaceutical manufacturing environment.
  • 7+ years of experience in manufacturing and supply chain areas.
  • 8+ years of direct supervisor/personal management experience.
  • Advanced knowledge of cGMP/GDP/pharmaceutical regulations and applications.
  • Advanced knowledge of microbiology and best cleaning practices.
  • Strong knowledge and application of OSHA, DEA, USP, and other applicable WH regulations.
  • Proficiency in ERP systems/WMS applications and analytics tools.
  • Proficiency in MS Office applications.
  • Strong written and verbal communication skills.
  • Intermediate presentation development and delivery skills.
Working Conditions:
  • Intermittent walking and sitting to perform job functions.
  • Physical dexterity to effectively use computers and documentation.
  • Vision and hearing capability to work in job environment.
  • Lift maximum of 25 pounds.
  • Ability to work around laboratories and controlled, enclosed, restricted areas.
  • Wear required cleanroom garments and personal protective equipment, including PAPRs.
  • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
  • Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components.
  • Areas may prohibit food, any outside materials, cell phones, and tablets.

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