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 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 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 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 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, Solo 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.
Ability to learn new concepts in measurement sciences outside of core expertise and training and the application to problem solving
Ability to work in a team environment with cross-functional interactions and influencing skills
Evidence of strong cross-functional collaboration in an industrial setting
Preferred Experience and Skills:
Familiarity with early to late-stage CMC analytical deliverables including development and the successful execution of GMP validation protocols and tech transfers to commercial laboratories.
Experience in areas such as, continuous monitoring using process analytical tools, or lab automation/informatics.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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Job Posting End Date:
05/11/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R344289