MFG 7 Downstream Lead (Associate Director)

WuXi Biologics

Dundalk, Ireland

As the MFG 7 Downstream Lead (Associate Director), you play a crucial role in supporting biological product production at the Dundalk facility, working closely with manufacturing teams. Reporting to the Manufacturing Lead, your responsibilities are two-fold: initially, you'll be pivotal in establishing the Manufacturing Department during start-up, ensuring operational readiness and providing essential input to meet end-user requirements. Post start-up, your focus shifts to leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs).

Collaborating closely with the Management Team (MT) and Material Science & Technology (MSAT) teams, you'll oversee the seamless tech transfer of products and processes to the Dundalk Facility. This involves ensuring effective collaboration and maintaining operational efficiency throughout the production lifecycle. In essence, your role combines strategic vision with operational leadership, driving excellence in production and ensuring the facility's success.

Key member of Manufacturing leadership team for WuXi Biologics Ireland. 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;
Lead a team of Shift leads, Specialists and Bioprocess associates to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility;
Supervise daily Downstream manufacturing activities and ensure production timelines are met;
Collaborate with MT and MSAT groups on technical transfer and process validation;
Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections;
Provides working knowledge and technical leadership in Downstream operations;
Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly;
Motivate, retain, develop existing group members, and recruit new staffs to build a strong Downstream manufacturing team;
Contribute to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear;
Communicate operational status regularly to senior management, as required, at the appropriate level of detail;
Assist the MFG 6/7 Lead to coordinate the work between the Downstream groups and other functional groups to meet the production objectives and timelines;
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 MFG 6/7 Lead.

Education:

Certificate, Diploma, Degree, or equivalent in Science, Engineering, or related field.

Knowledge/Education:

BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology. Master’s level qualification is advantageous;
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.

Experience:

More than 10 years in biopharmaceutical manufacturing with extensive experience in Downstream processing;
Experience in the large-scale chromatography, ultrafiltration/diafiltration, and viral inactivation and filtration;
Experience in dealing with FDA, and/or EMA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control;
Experience in working with the cross-functional teams;
Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer, and process validation;
Ideally, experienced in establishing a Manufacturing department and building a team in a ‘greenfield’ context.

Personal Skills:

A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports;
Excellent verbal and written communication and presentation skills;
Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation;
Ability to work on own initiative and be proactive;
Results oriented, with the ability to manage multiple priorities in a short period of time;
Excellent organisational and planning skills and strong attention to detail.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job