Manager, Zimura Drug Substance Manufacturing
- Employer
- IVERIC bio
- Location
- New York City, NY
- Start date
- Sep 28, 2020
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- Discipline
- Engineering, Manufacturing & Production, Manufacturing/Mechanical, Materials/Inventory Control, Operations, Supply Chain, Science/R&D, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
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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.
RESPONSIBILITIES:
- 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
QUALIFICATION:
- Minimum Bachelor’s degree in Chemistry or equivalent.
- Minimum 10 years of industry experience with at least 5 years of experience in GMP manufacturing.
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