Senior Scientist, Biologics Drug Substance Commercialization Process Analytics

Merck•Upper Gwynedd Township, PA

4d•$117,000 - $184,200•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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 documentation practices.
High level of proficiency with data analysis and visualization tools.
Experience with Empower or other chromatography data systems.
Strong attention to detail and quick learner.
Motivation to learn new skills, willingness to take on new challenges, and scientific curiosity.

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.