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- The candidate will be responsible for oversight of internal process development activities and oversight of external manufacturing partners for the internal portfolio
- Ensure development of phase-appropriate drug substance processes for portfolio of bispecific antibodies and cytokine fusion molecules, including cell banking, upstream cell culture, and downstream purification
- Identify opportunities to streamline CMC development opportunities and work cross-functionally to evaluate and implement these strategies
- Identify, select, and manage CMO and CRO vendors, including assistance and oversight on due diligence efforts, audits, site visits, and person in plant for drug substance manufacturing campaigns
- Collaborate with both external partners and internal teams to ensure timely batch disposition and support investigations and deviations as needed
- As a member of global project teams, actively collaborates with Research, Project Management, Regulatory Affairs, Drug Product Manufacturing, and Quality to incorporate CMC development plans to support program and corporate goals; communicates risks and appropriate mitigations to ensure key goals are met on time
- Lead and mentor scientists/engineers with upstream and downstream processing expertise by fostering an environment for career growth
- Author and review relevant sections of regulatory filings, IND/IMPD, BLA, MAA, etc
- BS/MS/PhD in a relevant biotechnology or scientific discipline
- 10+ years experience in biologics process development and a strong working knowledge of antibody processing, including upstream and downstream processes
- Experience working with and managing external contract manufacturing organizations (CMO)
- Experience with protein purification, filtration, and analytical characterization
- Experience working in regulated cGMP/GxP environment required and working knowledge of cGMP/ICH/FDA/EU regulations
- Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and "can-do" attitude.
- Flexible attitude - able to adapt to new information and generate appropriate process and/or manufacturing strategies
- Strong verbal and written skills; ability to provide focus and clarity and communicate key information to stakeholders; able to handle confidential information and material appropriately
- Must have proficient computer skills and be experienced using MS office software (Word, Excel, PowerPoint, Project).
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Senior Director, Drug Substance Process Dev and Manufacturing - Boston, United States - HireMinds
Description
Senior Director, Drug Substance Process Dev and Manufacturing
We're seeking a highly motivated and talented manager to lead our drug substance process development and manufacturing team. The successful candidate will play a key role in overseeing internal process development, technology transfer, and external manufacturing to support the development portfolio. This is a great opportunity for an individual to leverage their leadership and technical capabilities as we advance our clinical development portfolio. Overall, the successful candidate will be a key member of the talented CMC team and play an important role in bringing novel therapies to patients.