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SalaryJob Description
The Cell Manufacturing Operations Senior Specialist will operate as a process expert for cell therapy production and a project lead within cell manufacturing. This position contributes to technology transfer projects within the GMP cell processing operations team and ongoing oversight of Manufacturing Operations during the clinical phase of production. The incumbent will have expertise in cell culture, GMP, and project management skills. This is a full-time role and will require up to 50% travel, including international travel.
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or
On-Site: work five days per week on-site with ad hoc flexibility.
Key Duties and Responsibilities:
- Oversee and support clinical product manufacturing for cell therapy according to cGMP standards
- Provide experience-related information to drive more efficient technology transfer and final process development to the Manufacturing group. Assist in the development of controlled documentation including SOPs and Batch Records for manufacturing
- Ensure cGMP compliance through manufacturing oversight and tracking
- Monitor scheduling and assists with coordinating Vertex-supplied resources such as materials and personnel to ensure seamless operation of manufacturing activities
- Manage individual projects, including managing timelines and leading small group meetings
- Support the management of unexpected events
- Serve as the main technical SME for the team, troubleshoots problems independently
- Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking
- Other duties and projects as required to meet departmental requirements
Knowledge and Skills:
- Minimum of 3 years cell culture experience, ideally in both adherent and suspension cultures
- Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems
- Extensive experience with technical writing
- Minimum 6 years working experience in relevant field (may be reduced based on education level)
- Extensive GMP experience, including as a lead or trainer
- Expertise in cell processing technologies for GMP production
- Experience with bioreactors for cell culture
- Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
Environment:
- Works in a cleanroom and office setting
- Must be able to remain in a stationary position up to 50% of a workday during cleanroom processing activities
- Frequently move about inside the cleanroom to oversee process tasks
- Compressed gasses and LN2 are used in this process
#LI-Hybrid
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.
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.
