Director/Senior Director Drug Substance Antibodies

• Lead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.
• Work with internal and external stakeholders to achieve on time targets.
• Regulatory data creation to author documentation supporting filings and responses to health authorities globally.
• Manage leadership and operational functions such as budget requirements, mentorship and presentation of project achievement and initiatives to company executives.

Requirements

• PhD in related area with 10-15 years of industry experience in process development, drug substance and or manufacturing.
• 3-5 years of leadership experience of direct reports and career development of subordinates.
• Regulatory experience such as contribution to IND, BLA filings, health authority interaction and responses.
• Successful regulatory filing for biologics strongly preferred.
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