AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

The Senior Manufacturing Planner/Scheduler is an integral part of the Operational Management team whose role plans and optimizes the manufacturing and support activities including but not limited to ensuring readiness of equipment, raw materials, and documents by aligning all stakeholders timely with the goal of eliminating potential disruptions to manufacturing and overall operations.

 

PRINCIPAL RESPONSIBILITIES:

  • Align with Site Head and Site Leadership Team to maintain the Site Master Schedule
  • Maintain, update, and revise finite schedule of manufacturing operation including but not limited to the manufacturing unit operation, CIP, SIP, Validation Activities, Maintenance Activities, Product Change Over activities, and Room cleaning activities
  • Keep clear communication channel with Site Leadership Team to escalate and advise schedule conflicts, resource issues, etc
  • Liaison with cross-functional teams and operations management to ensure appropriate labor, machine and scrap standards are considered in the Production schedule.
  • Improve finite schedule tool to enable appropriate level of planning can be done
  • Communicate and revise any changes to the finite schedules in timely manner to all stakeholders
  • Summarize daily/weekly production/support schedules daily and communicate to stakeholders
  • Keep adherence to schedule metrics
  • Ensure campaign readiness of a new campaign timely
  • Coordinate with Manufacturing and Engineering Team to ensure all calibration, preventive maintenance, and corrective maintenance activities are performed timely
  • Coordinate with MSAT, manufacturing, and Quality organization to ensure all documentations are updated, approved, and printed for all manufacturing operations as well as any activities leading to manufacturing
  • Work closely with SCM to assure materials are available as needed and escalate if any issues arise
  • Lead decision making involving any schedule changes
  • Establish and lead internal processes and leverage systems to efficiently plan & procure in a growth-oriented environment.
  • Understand, communicate, and escalate any issues impacting planed production set by the site master schedule
  • Provide timely input in various meetings.
  • Establish and maintain rapport with all levels of internal customers
  • Provide information to our customers when required.
  • Perform other duties as assigned.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Knowledge of Good Manufacturing Practices (GMP) and Standard Operating Procedures.
  • Good communication skills, written and verbal, in the English language and good presentation skills.
  • Intermediate/advanced in the use of Microsoft Office Suite software such as Excel, Project, Project BI, Word, and PowerPoint, High proficiency in Excel is a must (macro programming)
  • Demonstrated skills in team building, collaboration, and resolution
  • Knowledge of Mab manufacturing routine operations
  • Knowledge in problem solving techniques
  • Good analytical skills
  • Outstanding attention to detail and organizational skills
  • Exceptional negotiation and meeting facilitation skills
  • Self-starter and independent worker who is able to work in a fast paced environment under pressure
  • Ability to multi-task and exhibit great time management discipline
  • Must be able to participate in the urgent after hours support of the facility

 

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in Scientific related discipline preferred or equivalent combination of education and relevant experience is required
  • 5+ years of experience Production Planning of which 3+ years of experience in a GMP pharmaceutical environment required
  • APICs or PMP certification preferred
  • Experience with an ERP preferred
  • Working knowledge of Capacity Planning and forecasting is a plus
  • Experience in multiproduct facility environment preferred

 

COMPENSATION BAND:

$87,417 - $104,900

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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