About the position
The Data-Rich Measurements (DRM) Group within Analytical R&D Enabling Capabilities organization is seeking a highly motivated individual as a Senior Scientist at its West Point, Pennsylvania location. The DRM group is responsible and accountable for executing a modality agnostic integrated analytics strategy across our Company's 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 a highly collaborative and motivated team of scientists in our company's Analytical Research and Development in partnership with process development scientists and engineers primarily for the vaccines’ portfolio with potential extension to other modalities. This is a laboratory-based role where 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 our Company's 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 to proactively identify technologies while championing their evaluation and their successful incorporation to existing workflows. Applicants must have effective communications skills (both oral and written), show scientific curiosity demonstrated through research and publications. As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines and vaccines of tomorrow.
Responsibilities
- Execute a modality agnostic integrated analytics strategy across the Research Laboratories’ Division.
- Assess enabling opportunities as programs enter the development pipeline.
- Collaborate with a team of scientists and engineers for the vaccines’ portfolio.
- Integrate process analytical technologies (PAT) to pipeline programs.
- Serve as a PAT subject matter expert on program teams.
- Apply a diverse PAT toolkit in support of early to late-stage programs.
- Advocate for the use of PAT to enable business outcomes.
- Develop, optimize, and execute phase appropriate validation strategies.
- Monitor and control drug substance and drug product quality attributes.
- Maintain a strong internal and external network to identify technologies.
Requirements
- Ph.D. in Chemistry/Biochemistry or related field, or a M.S in Chemistry/Biochemistry with 3 years of relevant experience in the biopharmaceutical industry.
- Knowledge of large molecule process development and/or pilot scale manufacturing.
- Proficiency in several PAT techniques including Raman coupled with MVDA, online/at-line chromatography coupled with MALS/UV/CAD/ELSD, flow VPX, benchtop NMR.
- Familiarity with continuous monitoring using process analytical tools or lab automation/informatics.
- Ability to deliver complex objectives under aggressive timelines.
- Demonstrated scientific ability through publications and presentations.
- Excellent verbal and written communication skills.
- Ability to learn new concepts in measurement sciences and apply them to problem solving.
- Ability to work in a team environment with cross-functional interactions.
- Evidence of strong cross-functional collaboration in an industrial setting.
Benefits
- Inclusion and diversity commitment.
- Equal Opportunity Employer.
- Flexible work arrangements.
