SUMMARY

Reporting to the Head of Manufacturing, the Head of Downstream 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 leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Head of Downstream will work closely with the management team and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the MFG11 Facility.

QUALIFICATIONS

• BSc, MSc, or PhD in Chemical Engineering, Bioscience, or Biotechnology. Masters level qualification is advantageous.
• More than 10 years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
• Experience in 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 systems in terms of deviation, investigation, CAPA, and change control.
• Experience in working with the cross-functional teams.
• Experience in troubleshooting and investigating critical deviations, and making the risk analysis on the development, technical transfer, and process validation.
• Must be quality-focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations

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

LI-AM

• Key member of the 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.
• 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 staff to build a strong Downstream manufacturing team
• Contribute to continual improvement of all manufacturing documentation (SOP MBRs, OJTs) 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 Head of Manufacturing in coordinating the work between the Downstream groups and other functional groups to meet the production objectives and timelines.
• Perform all duties by 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 the wider organization in adherence to the WuXi corporate core values and PROUD culture.