Senior Scientist- Process Analytical Technology, Cell & Gene Therapy

Job Description

General Summary:

The Analytical Development Senior Research Scientist consistently demonstrates a high level of strategic planning and experimental execution working within established timelines. Works with a high degree of independence and demonstrates the ability to lead a team, either formally or informally, to achieve experimental and organizational goals. Takes a leading role in writing documents (method documents, protocols, reports) and demonstrates high level analytical skills and understanding of data interpretation. Actively seeks cross-functional roles to improve communication between groups and achieve efficiency in achieving organizational deliverables.

Key Duties and Responsibilities:

• Evaluate and develop analytical methods for real-time monitoring of cell therapies using enabling technologies and traditional process analytical technologies.
• Evaluate and develop on-line, in-line, or at-line analytical methods for process monitoring, in-process analytics, and process characterization
• Develop, qualify/validate and implement spectroscopic methods (Raman, NIR, FTIR) either in non-GMP and GMP environment for process monitoring of biologics and cell therapy processes such as mAbs, proteins, viral vaccines, cell or gene therapy. Preferred experience with cell therapy products.
• Develop, qualify/validate and implement biocapacitance and other novel cell density monitoring platforms either in non-GMP and GMP environment for biologics or cell and gene therapy. Experience in cell therapy is a plus.
• Develop assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Experience with in-line probes, such as capacitance and Raman spectroscope, and development of statistical and regression models using advanced data analytics.
• Experience developing at-line or online methods using process automation, miniaturization, or high-throughput analytics.
• Experience in implementing RAMAN, Biocapacitance and other PAT tool in the GMP environment for biologics or cell and gene therapy.
• Experience in professional capacity developing soft sensors and statistical process models using data science approaches such as ML and AI.
• Familiarity or experience with robotic liquid handlers such as TECAN or Hamilton, and AMBR bioreactor system, BRX and their associated scripting software.
• Maintain excellent written documentation (e.g. lab notebook and test forms).
• Collaborate internally with process development and manufacturing teams to evaluate and test novel real-time monitoring technologies.

Knowledge and Skills:

• Hands-on experience with evaluating and/or implementing PAT tools for real-time monitoring of bioreactor.
• Experience using ML such as PCA, PLS, and clustering methods.
• Experience developing and deploying chemometric models for quantitative analysis of bioreactor status.
• Proficiency with scripting languages such as Matlab, Python or R and analytical softwares such as JMP, SIMCA, Unscrambler, etc.
• Familiarity with data visualization tools such as PowerBI, Spotfire.
• Understanding of bioprocessing, cell and gene therapy process development, characterization, and manufacturing.
• Ability to use literature to design proof of concept studies.
• Experienced writing technical documents including development reports, qualification protocols and qualification reports.
• Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented,multitasking, goal and timeline oriented, and critical thinker.
• Team player, innovative, collaborative, and initiative.

Education and Experience:

• Ph.D in Materials Science, Physics, Analytical Chemistry, Chemical Engineering or related discipline with 2+ years of industry experience or an MS with 5+ years of industry experience

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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