Senior Scientist, Biologics Drug Substance Commercialization Process Analytics

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
Required
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 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.
Be a Catalyst for Innovation! If you’re passionate about analytical science, thrive in a collaborative environment, and are ready to help shape the future of biologics drug substance commercialization, apply now and be part of a team driving scientific excellence and impact!
Required Skills:
Adaptability, Adaptability, Analytical Thinking, Biologics, Bioreactors, cGMP Regulations, Chemical Engineering, Chemistry, Chromatographic Techniques, Clinical Judgment, Commercialization, Corporate Ethics, Cross-Functional Project Management, Data Analysis Tools, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Method Improvement, Next Generation Science Standards, Pharmaceutical Products, Process Design, Process Development (PD), Process Optimization, Process Scale Up, Regulatory Submissions {+ 6 more}
Preferred Skills:
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The salary range for this role is
$117,000.00 - $184,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compens