Job Opportunity

Job Opportunity

Director, Manufacturing Technology

Director, Manufacturing Technology

United States Posted 2024-02-08

Director, Manufacturing Technology

Job Summary

Reporting to the Head of Manufacturing, the Manufacturing Technology Lead will play a pivotal role in establishing the Manufacturing Department initially during start-up by supporting operational readiness and providing operations input to ensure the facility design meets end user requirements and latterly, post start-up, by supporting the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Manufacturing Technology Lead will ensure ongoing optimization of the process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic.

Responsibilities

Key member of Manufacturing leadership team for MFG11. Will play an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
Provide technical expertise to the manufacturing team in support of the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility
Provide technical expertise in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert.
Provide Operations input/support to the design, commissioning and qualification of the new manufacturing facility at Worcestor through to commercialization.
Key player on the Operational Readiness team during start up, interfacing with the project to ensure the manufacturing facility will operate as per the user requirements.
Provide technical expertise for the manufacture of bulk drug substance in a cGMP regulatory environment.
Lead complex process investigations on the production floor is support of deviation resolution.
Subject Matter Expert for trouble shooting process issues during start-up, tech transfer activities and commercial operations.
Ensure highest Quality & Compliance standards.
Responsible for driving a culture of continuous improvement such as: problem solving, reducing cycle time, lean principles within the process.
Coach manufacturing personnel to increase technical knowledge of critical process steps on the floor.
Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
Provide ongoing coaching and support to cross functional team members, to share manufacturing best practices.
Participate in safety, process and environmental investigations. Reviews alert and action limits as needed and implements corrective action as appropriate.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents
Will be flexible to take on additional tasks and responsibilities at the discretion of the Head of Manufacturing
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture

Qualifications

More than 10 years’ experience in a large-scale biologics manufacturing facility.
Previous experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
Thorough knowledge of current Good Manufacturing Practices (cGMP).
In-depth working knowledge of manufacturing operations.
Third level qualification in a Science or Engineering related subject. Masters level qualification is advantageous.
Excellent focus and attention to detail.
Excellent communication, decision making, people influencing and project management skills.
Demonstrated problem solving capabilities.
Demonstrated ability to lead a technical team (Engineers & Scientists) as part of a cross functional collaborative organisation to achieve mutual goals.
Demonstrated ability to work independently and as part of a cross functional collaborative team to achieve mutual goals.
Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
Results oriented, with the ability to manage multiple priorities in a short period of time.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

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