Sr. Manager - Manufacturing

Celltrion Branchburg, LLCBranchburg Township, NJ
Hybrid

About The Position

As a Manufacturing Leader, you will be responsible for providing support to a process team, specifically focusing on safety, quality, and manufacturing performance. You will provide daily supervision of an area within manufacturing and be responsible for production timelines and department goals. Your responsibilities will include process planning activities, setting schedules, coordinating interactions and services from other groups, internal and external, to the manufacturing organization, and assigning daily work tasks. In addition, you will be hiring, developing, coaching/leading, and training manufacturing operators in the assigned area.

Requirements

  • Qualified candidates must be legally authorized to be employed in the United States.
  • This role requires flexibility and ability to make critical decisions 7 days/week.
  • This position requires wearing clean room attire.
  • Must meet the physical requirements of the job, ability to: Lift a minimum of 25 lbs.
  • Bend, reach, stretch, climb ladders, and work in tight spaces.
  • Stand for long periods.
  • BS with a minimum of 2 years of relevant experience or HS diploma/GED with a minimum of 7 years of relevant work experience.
  • Bachelor’s degree in biology, Chemistry, or related discipline, or HS Diploma with relevant work experience.

Nice To Haves

  • Project management skills.
  • Skills in communication, conflict resolution and managing complexity with exceptional skills to communicate decisions effectively, clearly, and accurately to staff and upper management.

Responsibilities

  • Ensure production activities comply with cGMP guidelines.
  • Follow all documentation and standard operating procedures.
  • Set priorities, process execution, work assignments, and reprioritize as required.
  • Responsible for providing support to respective process team, per corresponding Manufacturing Standard for Operational Excellence - 602.
  • Lead daily meetings, setting priorities, planning process, and assigning work.
  • Act as a liaison between Process Teams and frontline staff.
  • Responsible for cGMP compliance, ensuring that all production equipment is properly validated, and procedures are maintained within validated state.
  • Monitor shop floor metrics on a regular basis to ensure Operational Excellence in shop floor execution (e.g., safety, environmental and quality)
  • Provide relevant input to revisions of standard operating procedures and batch records.
  • Conduct periodic verifications of procedures as required and ensuring standard operating procedures reflect best practices.
  • Review technical reports.
  • Conduct and/or support deviation investigations.
  • Ensure that all production equipment is properly maintained, production areas are inspection ready, and production processes meet quality standards.
  • Serve as area advocate in cross functional meetings.
  • Champion company policies to area staff.
  • Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation.
  • Communicate safety and maintenance problems, status of operations, and employee related issues in a timely manner to management.
  • Influence the decision-making process to achieve optimal and timely resolution of issues.
  • Being an engaged member of the leadership team and having an appropriate presence in the floor.
  • Ensuring open lines of communication and clear messaging at all levels.
  • Measure and appraise operator performance against job duties, objectives, and goals.
  • Provide accurate and timely feedback.
  • Recommend merit increases, promotions, hires, and terminations.
  • Train personnel in manufacturing process/operations following standard operating procedures and cGMP guidelines.
  • Mentor/coach staff as well as lead staff with a high level of honesty and integrity.

Benefits

  • Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits.
  • This role requires up to 10% travel, on-call availability, and may involve shift work.
  • Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.
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