$150K — $200K *
Magenta Therapeutics a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients by making the process more effective, safer and easier. A culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference are at the very core of our progress in pursuing this vision.
Magenta Therapeutics is seeking an individual to provide chemistry technical oversight for small molecule APIs (i.e. synthetic peptide) and key starting materials / intermediates (i.e. drug-linker for ADCs). Reporting to the Head of CMC, the candidate is responsible for leading process development and manufacturing activities and assures all CMC deliverables are met. This includes chemistry and process optimization, tech transfer to CMO, manufacturing support, commercial scale development, and regulatory filings. The chemistry lead will drive deep scientific knowledge of process chemistry and process development. In addition, the candidate will provide technical support for in-process controls, specifications, release/stability testing and drug formulation. She/He will work with SME’s, Quality, CMC Regulatory, and external CRO/CMO to define the strategy for small molecule CMC development and a phase appropriate control strategy. The chemistry lead is responsible for project planning and assures both timeliness and high quality of deliverables. This candidate will also represent the chemistry function in the integrated project team(s) and collaborates with partner functions to guide CMC and process optimization for small molecules.
You are perfect for this role if you are engaged by:
• Leading and management of process development, tech transfer and manufacturing through the CMO network
• Technical oversight for process chemistry for synthetic peptide, small molecule, and drug-linker.
• Building and maintaining a network of trusted development and manufacturing partners
• Participating in assessment and approval of GMP change controls, investigation, and follow-up of corrective actions.
• Authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, BLA/MAA etc.)
• Collaborating effectively with the Project Management, Discovery, Quality, and Regulatory groups to meet program goals.
We would be thrilled if you brought the following with you:
• MSc/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent, 10+ years of relevant experience in small molecule drug development covering process chemistry, drug product development, scale-up, and tech transfer
• Must have hands-on experience in process development, tech transfer, and manufacturing support for small molecules.
• Familiar with release and stability testing
• Familiar with synthetic peptide synthesis and bioconjugation
• Willingness to be both a strategic leader and a hands-on problem solver
• Experience in oversight of CMOs/CROs for process development and manufacturing
• Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities while maintaining attention to detail
• Clear and succinct verbal and written communication skills
• Strong analytical, problem solving and critical thinking skills
• Ability to influence others and work independently and in a team environment
• Ability to travel within the US and internationally up to 15-20%
Successful leaders and contributors within Magenta are:
Valid through: 8/13/2020
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