Supervisor, Manufacturing Assembly

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

Supervisor for manufacturing assembly in a sterile cGMP environment, focusing on lentiviral vector production. Responsibilities include leading daily production, ensuring compliance, managing investigations, revising procedures, and collaborating with cross-functional teams. Requires strong leadership, problem-solving, and communication skills, with experience in cGMP environments.

What you'd actually do

  1. This individual will lead and supervise the lentiviral vector end to end manufacturing process according to standard operating procedures, batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
  2. Will lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
  3. The primary responsibility will be to work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
  4. They will support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls. Will work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
  5. This individual will need to build strong partnerships with Manufacturing investigations, Facilities, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.

Skills

Required

  • Knowledge of cGMP regulations and FDA guidance related to manufacturing of drug substance products, and cleanroom behaviors.
  • Strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
  • Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
  • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
  • Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
  • Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
  • Ability to accommodate shift work including evenings and weekends as required by the process.
  • Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records
  • A working leader who can participate in production runs in critical situations when needed.
  • Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
  • Prior experience in manufacturing, quality, or engineering is required.
  • Excellent communication and organizational behaviors skills are required.
  • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
  • Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
  • Experience working in cGMP systems

Nice to have

  • A minimum of two (2) to four (4) years of operations experience within a cGMP environment in the biotech/biopharma industry is preferred.
  • Prior experience in an aseptic manufacturing environment and leadership positions.
  • Experience with Operational Excellence and/or Lean Manufacturing is an asset.

What the JD emphasized

  • Supervisor
  • Manufacturing Assembly
  • lentiviral vector
  • cGMP
  • aseptic manufacturing