- Provide leadership for LVV vector and cell manufacturing process validation, process changes and improvements, process tech transfers, deviation investigations, and change management.
- Collaborate with cross functional team to develop PPQ readiness strategy and take ownership of MS&T related PPQ-enabling deliverables during late stage process development and characterization
- Act as owner of late stage and commercial Process Control Strategy
- Provide oversight for continuous process monitoring to ensure compliance to validated stated throughout the product lifecycle
- Become primary point of contact for routine manufacturing support including acting as Person-in-Plant at CDMOs, reviewing and approving batch records, and supporting all batch disposition activities
- Lead systematic root cause investigations and product impact assessments for critical quality events
- Develop strong cross-functional relationships with manufacturing, process development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement.
- Lead authoring and review MS&T owned documents, including protocols, reports, risk assessments and Module 3 sections for IND and BLA submissions.
- Collaborate with process development, manufacturing, supply chain, and quality assurance in the identification and implementation of lifecycle improvements including process optimization and new or second source raw materials
- PhD/MS/BS in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline
- PhD with 6 years, MS with 10 years, or BS with 12 years of late stage and commercial drug development. Gene therapy experience is not required but is preferred.
- Demonstrated ability to work in a self-driven, performance results/performance-oriented, fast paced environment
- Proven track-record for late-stage clinical manufacturing support and process validation execution and authoring related CTD sections
- Demonstrated ability to perform and document complex manufacturing process
- Motivated to drive and own functional initiatives and influence peers and stakeholders to collaborate and accomplish key milestones
- Experience with cGMP, ICH guidelines, process validation, and control strategy development
- Excellent verbal and written communication skills
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Associate Director, MS&T - Cranbury, United States - Rocket Pharmaceuticals
Description
Overview
Work at ROCKET PHARMA and help cure rare diseases
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary
The MS&T department is seeking a highly motivated Associate Director to be responsible for late stage and commercial LVV development, commercialization, and lifecycle management. The successful candidate will be responsible for technology transfer, process improvement implementation, process validation and technical support of late phase and commercial GMP manufacturing activities for LVV drug substance and drug product. The ideal applicant will have a strong background in manufacturing and validation of LVV or biologics. The incumbent will collaborate with cross-functional department colleagues within Rocket Pharma as well as external partners to ensure the successful execution of GMP production.
Responsibilities
Implement validation strategies for LVV products with direct responsibility over the execution of process validation and supplemental validation activities
Qualifications
EDUCATION REQUIREMENT:
EXPERIENCE & SKILLS:
