The Director of Manufacturing will be responsible for managing process development/technology transfer of manufacturing processes to contract manufacturing organizations (CMOs) and management of the GMP manufacture for clinical supply of novel drug substances. The Director of Manufacturing will also support internal and external process development activities including CMO due diligence, process scale up, data trending activities, and regulatory filings.
Our biotech clients seek director level engineers who are career-driven and have strong, technical leadership and mentoring skills. It is important that they have successfully managed complex process development relationships with contract manufacturers. Our companies offer excellent career growth potential and benefits. We have many opportunities – all with top companies seeking on the best process development engineering.
typical roles and responsibilities for Director Manufacturing
Resolve complex manufacturing issues through collaboration with the process development and manufacturing teams.
Working closely with a team of scientist leaders and engineers you will lead successful GMP manufacture of RNA drug substance.
Work cross functionally with R&D, quality and validation to ensure FDA and other notified bodies compliance
Manage working relationships with contract manufacturing partners
Requirements for the Director of Manufacturing
Bachelor’s degree in engineering; advanced degree preferred
10+ years of relevant manufacturing process development or engineering experience in the pharmaceutical or biotechnology industry
A broad understanding of process engineering/development of biologic or nucleic acid drug substance
Demonstrated ability to manage technology transfer and scale up of drug substance manufacturing processes
Experience managing GMP manufacturing operations for clinical or commercial drug substance
Proven ability to work in a matrix team environment solving complex technical and equipment qualification challenges
Proficiency with quality by design concepts, mathematical modeling software for design of experiments and data trending, statistical process control, and complex data analysis
Knowledge of relevant cGMP and quality guidelines
Experience in providing scientific and technical due diligence support for business development activities
Excellent oral and written communication skills
The ability to manage multiple competing projects
Strong statistical and analytical skills
Travel to contract manufacturing sites to support manufacture and technology transfer is required.