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Job Description General/Position Summary The MSAT Senior Scientist provides a critical technical role for the...
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Job Description
General/Position Summary
The MSAT Senior Scientist provides a critical technical role for the Commercial Manufacturing & Supply Chain, focused on Cell and Gene therapies, reporting to the MSAT Senior Manager/Principal Scientist. Under supervision, the Senior Scientist is responsible for product commercialization activities (PPQ, PLI readiness etc.), post-approval process monitoring (CPV, OOS, OOT and Deviation handling), and change management.
This is a Hybrid role based in Paddington, London
Key Duties & Responsibilities
Develops timelines, communicated with key stakeholders, to ensure MSAT activities are prioritized and executed to meet the requirements of the program. Contributes to cross-functional teams (VCGT, External Manufacturing, Supply Chain, and Quality functions) to ensure that process validation, technology transfer, deviation management, process monitoring and post-approval change management are managed within agreed processed and are on target.- Resolves issues independently, where possible, and escalates other risks appropriately.
- Partner effectively and manage relationships with external CDMOs and key suppliers to meet manufacturing and program goals.
- Through the development of process data driven reports, support compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
- Provide support and applicable manufacturing process related content for CMC regulatory submissions and assist with technical CMC regulatory/Agency questions.
Required Education Level
- Bachelor's Degree in science or related discipline is required, or equivalent experience.
Required Experience
- Experience with process development and technical support of commercial biological products and cGMP manufacturing. Experience with Cell and Gene therapies preferred.
- Knowledge of US and EU cGMP regulations/guidance.
- Experience with technology transfer, process validation and process monitoring.
- Direct experience working with contract manufacturing organizations (CDMO) and/or technical service partners.
- Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs.
Required Knowledge/Skills
Strong background in Cell and Gene Therapy pharmaceutical manufacturing processes and technologies.- Knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements related to pharmaceutical manufacturing.
- Experience with process development and scale-up of pharmaceutical manufacturing processes, including process optimization, troubleshooting, and validation.
- Experience with statistical analysis (including JMP) for process optimization and validation.
- Excellent communication skills, both verbal and written, with the ability to communicate complex technical information to a range of stakeholders.
- Strong problem-solving and critical thinking skills, with the ability to analyze data and make sound technical recommendations.
- Strong leadership skills to contribute to, and provide technical guidance to, cross-functional teams.
- Travel required: 25% primarily in the EU and some (limited) US travel.
#Hybrid
#LI-SM1
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit
www.vrtx.com
.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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