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) Click Here To Read Full Job
Description