Job Description

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

~ 5 PTO, 5 Sick, 2 Floating Holiday, 10 Paid Holidays
~ Benefits begin your first day of employment
~ Health - Cigna
~ Dental - Delta Dental
~ Life Mart - Employee discounts through ADP
~ 401k Retirement Investment Plan Traditional or Roth - Wuxi Biologics USA LLC matches 100% of the first 2% of employee contribution and 50% match on the next 4% employee contribution. Vesting schedule for the company match is 50% after 1 year of employment and 100% after 2 years of employment. To help you save for your future, Wuxi automatically enroll employees at 6% (You have 30 days to opt out of auto enrollment)


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