Principal Scientist, Analytical R&D (Process Analytical Technologies)

Job Description

The Data-Rich Measurements (DRM) Group within Analytical R&D Enabling Capabilities organization is seeking a highly motivated individual as a Principal Scientist at its West Point, Pennsylvania location.

The DRM group is responsible and accountable for executing a modality agnostic integrated analytics strategy across the Research Laboratories’ Division. This includes the proactive assessment of enabling opportunities as programs enter the development pipeline and progress along stage gates towards the late stage and prior to the supply space.

In this role, you will work with and provide technical leadership to a motivated team of scientists (~5) in the vaccines facing DRM organization in partnership with process development scientists and engineers within the vaccine’s process development and vaccines drug product development organizations.  This is a laboratory-based role wherein you will partner with a diverse team of scientists to integrate process analytical technologies (PAT) to pipeline programs to deliver on the development of robust, cost-effective processes while incorporating learnings to influence integrated process control strategies. The individual will serve as a PAT subject matter expert on program teams and apply a diverse PAT toolkit such as (e.g., online UPLC, Raman, FTIR coupled with advanced chemometric methodologies) in support of early to late-stage programs. The selected individual will proactively advocate for the use of PAT to enable business outcomes by partnering across the network with process, quality, and manufacturing teams to identify enabling opportunities. This role will also be accountable for developing, optimizing, and executing on phase appropriate validation strategies for online/in-line/at-line methods to monitor and control drug substance and drug product quality attributes in the development space with the intent of enabling seamless transfers to the commercialization space.  Additionally, the selected individual will be expected to maintain a strong internal and external network environment to proactively identify novel technologies while championing their evaluation and their successful incorporation into current and emerging workflows.

Applicants must have effective organizational, multi-tasking, oral / written communications skills, show scientific leadership, and a desire to conduct research and publish.  As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Education Minimum Requirements: 

• Ph.D. in Chemistry/Biochemistry/Chemical Biology or related field with 7-10 years of experience in the bio-pharmaceutical industry

Required Experience and Skills: 

• Scientific supervisory or mentorship experience
• Knowledge of vaccine process development and pilot scale manufacturing
• Proficiency in the use of data-driven qualitative and quantitative chemometric model building approaches (MVDA)
• Hands on experience in the use of PAT tools such as online UPLC, Raman, FTIR, Capacitance, aSolo VPE, Flow VPX etc.
• Experience in areas such as, continuous monitoring using process analytical tools, or lab automation/informatics.
• Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
• Demonstrated scientific ability through publications and presentations in scientific conferences.
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.

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