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.

• 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.

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…