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 to ensure excellence in execution.
• Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
• Actively interact with internal and external partners, representing your functional area on cross‑functional teams to foster collaboration and innovation.
• Author regulatory and technical documentation, ensuring all processes align with company expectations.
• Manage a small team of junior staff, guiding them in professional development.

• A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience.
• Ten (10) years of required experience with a bachelor’s degree, eight (8) years with a master’s degree, and four (4) years with a PhD.
• Proficient in the 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 to articulate complex concepts in a multi‑disciplinary team environment.
• Experience leading teams and fostering career development for junior staff.
• In‑depth knowledge of harvest, preparative chromatography, and filtration techniques (preferred).
• Experience in pilot or commercial scale manufacturing of biological molecules (preferred).
• Familiarity with late‑stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations (preferred).
• Proficiency in statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA) (preferred).