Manager Drug Substance Needed for a rapidly growing Biotech
* Fully Remote Position
* Competitive compensation package
The Manager Drug Substance will have the following 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 cross functionally with different departments: QA, Analytical, Regulatory and DP Manufacturing.
* Evaluate the tracking flow of projects against established timelines, and prioritize activities based on changing requirements.
The Ideal Candidate will have the following skill set:
* Bachelor's degree required with advanced degree preferred in Chemistry or similar field.
* Minimum of 10 years industry experience with at least 5 being in a GMP environment.
* Ideally looking for someone with prior experience with oligonucleotide manufacturing
* In depth background working with Master Batch Record Review
* Strong communication, time management, and self-motivated skills are required to work successfully in a remote environment.
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