Process Development Engineering Principal Associate (Contract) 24179

This role will be supporting the CMC organization within Vertex Cell and Genetic Therapies, which includes early and late phase programs. This position offers a unique opportunity to explore a breadth of experiences from pre-clinical activities to clinical production across a range of different modalities. This position will involve extensive collaboration across Process Development, Manufacturing, QA, QC, and Regulatory teams. This position will have a direct impact on driving programs towards commercialization. We are seeking an individual who is excited about implementing process improvements and troubleshooting clinical production issues within highly cross-functional environment.

Key Duties and Responsibilities:

• Provide cross-functional support in technology development and transfer from Development to Clinical Manufacturing including operations in Vertex manufacturing sites and CDMOs.
• Planning and implementing continuous improvement initiatives for life-cycle management.
• Lead the impact assessment for deviations, implementing CAPAs, updates to MBR and process descriptions in collaboration with PD, QC, QA, and MFG.
• Support PPQ activities.
• Data trending activities include, capturing data from sources into a database, implementing control charts and multivariate analysis techniques.
• Present findings on data analysis and change controls to senior management.
• Support CDMO activities including, attending cross-function meetings, identifying technical challenges and program risks.
• May require travel to external sites.

Knowledge and Skills:

• Cell therapy process development and manufacturing desirable.
• Upstream or downstream process development or MSAT.
• Experience in statistical methods using JMP or similar.
• Knowledge of analytical techniques such as, cell count & viability, flow cytometry, and cluster sizing.
• Knowledge of change controls, deviations, CAPAs, MBRs, and process description.
• Excellent technical writing skills.
• Effective communication skills especially on complex technical topics.
• Organization skills to handle parallel projects of diverse scopes.

Education and Experience:

• Bachelors or Master of Science or Engineering
• 5+ years of experience in CMC and Process Development activities
• Desirable - cell therapy, data trending, and statistical methods

Flex Designation:

100% onsite

$50-$55/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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