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
Benefits:
~ 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 – Our company 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, we automatically enroll employees at 6% (You have 30 days to opt out of auto enrollment)
Pay: $160,000.00 – $180,000.00 per year