Job DescriptionAs 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.
QualificationsRequired
- 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: Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
Employee Status: Regular
Relocation:Domestic
VISA Sponsorship:No
Travel Requirements:No Travel Required
Flexible Work Arrangements:Not Applicable
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:10/7/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
