Job Summary/Objective:
Oversees and interacts directly with CDMO to set all chemistry, manufacturing, and controls
(CMC), regulatory, and manufacturing strategies for new and mature products. Works with
quality and regulatory functions internally and externally to ensures strategies are
commensurate with the current regulatory and compliance environments. Works with and
provides guidance and support to internal groups such as marketing, national and international
supply chain teams, and external groups such as overseas partners, component and raw
material suppliers as well as to other outside groups as required to ensure that products are
manufactured in compliance with all applicable regulations. Provides strategic input and risk
assessments and oversees preparation of CMC regulatory submissions. Interacts with
regulatory agencies.
The Director, Manufacturing will work closely with supply chain, regulatory, and QA to ensure
commercial product quality and on time manufacture.
10+ years’ experience in the pharmaceutical industry, formulation development, analytical
chemistry, manufacturing, and combination products operating at a manager/ director level.
Travel Requirements:
• Ability to travel domestically and some overseas. 5 trips per annum.
Minimum Education and Experience Required:
• Degree in appropriate field (chemistry, pharmaceutical sciences, etc.)
o Education level: PhD (chemistry, pharmaceutical sciences, etc.) with 8+ years of
experience in industry OR MSc with 12+ years of experience in industry
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