Associate Principal Scientist, Biologics Drug Substance Commercialization; Associate Director

Responsibilities

• Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes.
• Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization.
• Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
• Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
• Interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
• Author regulatory and technical documentation to ensure processes align with company expectations.
• Manage a small team of junior staff and guide professional development.

• Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: 10 years (bachelor’s), 8 years (master’s), or 4 years (PhD).
• Proficiency in purification of biological molecules, including chromatography and filtration systems.
• Proven track record in tech transfer or scaling up processes for biologics manufacture.
• Exceptional oral and written communication abilities.
• Experience leading teams and fostering career development for junior staff.

• In-depth knowledge of harvest, preparative chromatography, and filtration techniques.
• Experience in pilot or commercial scale manufacturing of biological molecules.
• Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.
• Proficiency in DOE/statistical analysis, SPC, and multivariate analysis (MVA).

• Cross-functional collaboration, data analysis, leadership, mentorship, downstream processing/operations, manufacturing process validation, manufacturing quality control, manufacturing scale-up, process improvements.

• Annual bonus and long-term incentive (if applicable).
• Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

Apply at  (or via the Workday Jobs Hub if a current employee). Final date to receive applications is stated on the posting (Job Posting End Date: 04/25/2026; apply no later than the day before).