Actalent Senior Manager, Drug Substance in Cambridge, Massachusetts
The position is accountable for the development and implementation of Drug Substance supply at Contract Manufacturing Organizations. Our client is developing peptides designed to broadly inhibit complement C3, a central element of the complement cascade. The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to lead this key function for the organization.
Essential job functions:
• Ensure that all aspects of Drug Substance CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, and commercial standards.
• Accountable for leading teams to ensure process development, process characterization, scale-up, technology transfer, and process validation are successful.
• Oversees process development strategy and timeline to ensure phase-appropriate manufacturing processes and methods.
• Actively manage external development and manufacturing activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
• Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
• Maintain primary accountability for production plan, ensuring consistent material availability for all manufacturing activities, including adequate planning for long lead time items.
• Ensure qualified assays are established for analysis of in-process and Drug Substance.
• Ensure all appropriate documents are generated and retrievable.
Additional Skills & Qualifications:
• Life Sciences degree
• 5 years of experience in cGMP development and manufacturing
• Will be helping lead cross-functional teams, so need to be sharp!
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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