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Senior Manager Bulk Operations Manufacturing

Lead all activities in bulk production while ensuring compliance with regulations and quality standards.
UNAVAILABLE, UNAVAILABLE, CH
Expert
1 month ago
WuXi AppTec

WuXi AppTec

A global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company offering R&D and manufacturing services.

1 Similar Job at WuXi AppTec

Leadership Role

This role is a leadership position responsible for managing supervisors and/or production teams.

This position is a guarantee and a model for WuXi's values and skills.

General Missions:

Reporting to the Director of Production, the bulk production manager will be responsible for leading all activities in the sector. He/she sets production goals in compliance with regulations and safety constraints, quality, deadlines, and costs. He/she ensures a continuous improvement approach in productivity based on his/her technical knowledge of the processes. He/she coaches, trains, and motivates teams and supports them in the development of skills.

As a key player in product manufacturing, this position will also work closely with all departments on site.

Responsibilities

Essential Functions of the Position:

  • Responsible for the timely delivery of complete bulk batches, according to the production schedule, which you will review and approve to ensure the timely delivery of high-quality products.
  • Responsible for the bulk manufacturing KPI, ensuring that actions are taken to meet the KPIs.
  • Responsible for the performance management of the bulk entity using and developing different management tools (associated KPIs), Lean Manufacturing tools, and monthly activity balance.
  • Responsible for the efficiency of bulk manufacturing processes, ensuring they are properly documented. You will continuously improve processes, ensuring that relevant procedures and documentation are updated.
  • Responsible for the execution, traceability, and compliance of operations performed by the team in accordance with BPF. You monitor and analyze production data to identify trends, problems, and opportunities for improvement.
  • Responsible for the rapid investigations of all quality issues in bulk manufacturing. By reviewing and approving all investigations, you will ensure that the root cause has been identified, the follow-up of CAPAs, and that effective PACs are proposed.
  • Ensure representation of the bulk department during health authorities audits (FDA, Swiss Medic, EMEA…) and internal audits.
  • Comply with the guidelines and instructions defined in the site's EHS system.
  • Responsible for mentoring and coaching your direct supervisors and the manufacturing team, technicians, and operators, ensuring that the development plans of their skills and succession plans are documented for your direct subordinates.
  • In partnership with your superior, define the medium-term strategy of the Bulk department regarding activities, projects, and resource planning.
  • Ensure compliance with processes and animate the feedback.
  • Contribute to the organization of work and the management of priorities.
  • Master the adequacy of workload/capacity of employees and anticipate needs.

Management:

  • Animate the team and develop regular exchanges by deploying an efficient communication system: daily meetings, operational display.
  • Ensure the downward communication of the Management.
  • Carry with the management team the site projects and break them down to the team by setting qualitative and quantitative objectives.
  • Carry out regular feedback and ensure the evaluation of collaborators, notably through annual and professional interviews.
  • Organize and optimize each function, listen and encourage the participation of all.
  • Build the training plan of the team by seeking to develop the skills of the collaborators, the versatility of the team in a logic of performance and customer satisfaction.
  • Create a favorable context for the smooth running of the activity by promoting communication, generating a climate of trust and contributing to the cohesion of the group.

Qualifications

Knowledge / Skills / Abilities:

  • Solid practical knowledge to ensure the compliance of bulk activities with applicable regulations, GMP, FDA regulation.
  • Technical training and process expertise are assets.
  • Organized and rigorous, able to provide leadership coaching to maintain an environment of trust and personal responsibility.
  • Demonstrated ability to communicate effectively with the team but also at all levels of the organization.
  • Force of proposal and autonomy in decision-making.
  • Good mastery of common computer tools, Word, Excel, PowerPoint, PAS-X.
  • Autonomous and aptitude to work on the field.
  • Quality and integrity oriented.
  • Degree:

    • Degree from an engineering school or State Diploma of Doctor of Pharmacy
    • or equivalent Master's Degree MIPSC (Industrial Management, Projects, and Supply Chain).
    • Minimum 10 years of experience in the pharmaceutical industry, ideally in Bulk.
    • Minimum 5 years of experience in management and in GMP environment.
    • Languages: French and English fluent.
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Senior Manager Bulk Operations Manufacturing
UNAVAILABLE, UNAVAILABLE, CH
Operations
About WuXi AppTec
A global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company offering R&D and manufacturing services.