Senior Director, Process Development
3 weeks ago
Senior Director, Process Development
Waltham, MA
We're seeking a highly motivated and talented Senior Director 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.
Responsibilities:
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
Qualifications:
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).
by Jobble
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