Manager, Zimura Drug Substance Manufacturing
The manager is responsible for leading and managing the drug substance manufacturing at CMO to meet department timelines and material supply requirements, reports to Director Drug Substance and Manufacturing.
- Manage GMP manufacturing of API at CMO's working with CMO leadership team to drive manufacturing quality and excellence.
- Provide technical guidance for troubleshooting and investigating complex issues.
- Review of master and executed batch records.
- Writing of RFP's and review of quotes as appropriate.
- Provide support for regulatory filing activities.
- Provide status updates in departmental and CMO meetings.
- Work closely with QA, Analytical, Regulatory and DP Manufacturing.
- Detail oriented with strong communication skills.
- Evaluate the tracking flow of projects against established timelines, and prioritize activities based on changing requirements.
- Excellent writing, editing, and organizational skills required.
- Demonstrated ability to work remotely.
- Ability to develop trusted relationships with CMOs.
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels of the organization.
- Preferred experience with oligonucleotide manufacturing.
- Preferred experience managing contract manufacturers
- Minimum Bachelor’s degree in Chemistry or equivalent.
- Minimum 10 years of industry experience with at least 5 years of experience in GMP manufacturing.