Hiring: Associate Director Process Development Company: BioSpace Location: Thousand Oaks, CA Job Posted Time: 2026-09-10 10:23:45 About the job Experience: •3 years of experience in engineering or science •7 years of experience in engineering or science •9 years of experience in engineering or science •12 years of experience in engineering or science •14 years of experience in engineering or science Required Skills: •Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations. •Lead a team of scientists focused on late-stage drug product process development and tech transfer and coach staff with emphasis on people-centered leadership. •Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements. •Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering. •Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships. •Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions. •Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs. •Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis. Qualifications: •Doctorate degree and 3 years of experience in engineering or science •OR Masters degree and 7 years of experience in engineering or science •Bachelors degree and 9 years of experience in engineering or science •Associates degree and 12 years of experience in engineering or science •High school diploma / GED and 14 years of experience in engineering or science •And In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above •PhD from an accredited college or university in one of the following areas Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area •Demonstrated knowledge of drug product commercialization and integrated combination product development with hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations •Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites •Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!