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Senior Scientist, Biologics Drug Substance Commercialization Process Analytics

Job in West Point, Montgomery County, Pennsylvania, 19486, USA
Listing for: MSD Malaysia
Full Time position
Listed on 2026-10-02
Job specializations:
  • Science
    Pharmaceutical Science/ Research, Research Scientist
Salary/Wage Range or Industry Benchmark: 117000 - 184200 USD Yearly USD 117000.00 184200.00 YEAR
Job Description & How to Apply Below
Job Description

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Senior Scientist in Process Analytics, you'll be at the forefront of scientific problem-solving and technical leadership, partnering cross-functionally to support process development, method establishment, and lifecycle activities for a diverse biologics pipeline.

Your contributions will help ensure scientific rigor, analytical excellence, and operational readiness as programs transition from being supported in our research & development division analytic teams to BDSC Process Analytics.

Responsibilities
  • Provide insight, guidance, and scientific leadership to the broader team.
  • Serve as a technical leader for the Process Analytics team and support alignment and standardization efforts across programs and stakeholders.
  • Bring strong analytical experience to guide routine testing teams, support troubleshooting, and enable robust data analysis.
  • Identify opportunities to improve efficiency, strengthen methods, and support innovative approaches to analytical problem-solving.
  • Collaborate closely with drug substance and drug product process teams, broader analytical network, and other stakeholders to ensure integrated support across the product lifecycle.
  • Serve as a point of contact for late-stage pipeline and newly launched commercial programs and support effective testing prioritization across multiple projects and competing demands.
  • Demonstrate strong organizational and project management skills in a dynamic environment.
  • Support and oversee the establishment of new methods within BDSC Process Analytics team, including handoff from research analytic teams to BDSC Process Analytics, ensuring technical readiness for implementation.
  • Author technical protocols, reports, and regulatory documents in support of process comparability studies.
  • Demonstrate excellent ethics, compliance, and integrity while maintaining high standards for scientific rigor, documentation, and team expectations.
  • Provide support and guidance to the lab lead and help foster a collaborative, accountable, and high-performing team culture.
Qualifications
  • Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, Analytical Chemistry, Chemistry or a related field with six (6) years of required industry experience; OR Master's degree with four (4) years; OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, Analytical Chemistry, Chemistry or a related field with no minimum required experience.
  • Strong analytical background with the ability to provide technical guidance and sound scientific judgment.
  • Collaborative mindset and ability to work effectively across teams and functions.
  • Critical thinking and strong troubleshooting skills.
  • Ability to manage multiple priorities in a fast-paced, ambiguous environment.
  • High standards for ethics, compliance, and documentation.
  • Strong communication skills, both written and verbal.
  • Ability to influence without authority and build trust across teams.
  • Experience supporting process development and commercialization activities.
  • Preferred Knowledge of critical quality attributes of biopharmaceutical products and how to test them.
  • Experience with HPLC/UPLC/capillary electrophoresis executions and data analysis of therapeutic proteins using various techniques such as IEX, SEC, HIC, including method development and troubleshooting.
  • Familiarity with analytical characterization techniques including capillary electrophoresis, icIEF, ELISA, PCR, SoloVPE, and detection methods such as CAD, fluorescence.
  • Experience working as a productive member of cross-functional teams.
  • Strong written and oral communication skills for scientific audiences and broader organizations.
  • Understanding of ICH Guidelines and experience with current good manufacturing practices.
  • Experience with biologics commercial process development, including process characterization, process validation, and tech transfer.
  • Understanding of analytical method qualification.
  • Familiarity with small-scale sample purification using TECAN system.
  • Proven track record of collaborating across organizational boundaries to drive results.
  • Experience leading cross-functional teams.
  • Experience working with external partners in analytical or process engineering roles.
  • Experience with electronic laboratory notebook systems and good…
Position Requirements
10+ Years work experience
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