Hiring: Director- Purification- Process Translation and Execution Company: BioSpace Location: Lebanon, IN Job Posted Time: 2026-09-13 11:44:25 Employment Type: Full-time Target Skills & Keywords : Foundry, Root Cause Analysis About the job Experience: •12+ years of industry experience in biologics DS development or manufacturing, with 8+ years of direct experience in purification processes. Required Skills: •Team Leadership and Development •Lead, mentor, and develop a team of PTE scientists with deep technical expertise in downstream bioprocessing (chromatography, TFF/UFDF, viral inactivation, and viral filtration) across traditional biologics and mixed modalities (monoclonal antibodies (mAb), antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), peptides, oligonucleotides). •Foster a high-performance environment through regular coaching, one-on-ones, and performance feedback. Promote psychological safety and professional growth. •Technology Transfer and GMP Production Support •Provide technical oversight for clinical DS purification and conjugation process technology transfers from Process Development to Foundry cGMP operations. Lead/support facility fit assessments, risk analyses, and scale-up strategy to ensure right-first-time execution. •Serve as the primary SME on the manufacturing floor, supporting front-line process teams, leading complex deviation investigations and root cause analysis, and driving CAPAs to closure. •Collaborate cross-functionally to streamline tech transfer processes, accelerate timelines, and advance digitization of technical documentation and workflows. •Ensure Foundry processes remain compliant, capable, and in a qualified state throughout their lifecycle. Support tech transfer for product commercialization. Qualifications: •PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines. •Deep expertise in downstream unit operations including chromatography (affinity, ion exchange, mixed-mode), tangential flow filtration (TFF/UFDF), viral inactivation (low pH, detergent), and viral filtration. •Extensive experience in leading, coaching, and developing direct reports, fostering a culture of growth and accountability. •Applied hands-on capability in bioconjugation processes such as antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), or related conjugation processes. Familiarity with conjugation reaction optimization, DAR control, and post-conjugation purification including organic solvent handling at moderate scale. •Solid functional working knowledge of process analytical technology (PAT) for downstream operations, including inline UV, conductivity, and pressure monitoring for real-time process decisions. •Leadership in process innovation and continuous improvement, including complex deviation investigations, root cause analysis, and CAPA implementation. •Operational familiarity with emerging purification modalities relevant to next-generation biologics (e.g., mRNA purification, LNP downstream processing, or novel affinity ligands). •Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer. •Effective interpersonal and communication skills; strong conflict-resolution skills and experience in building cohesive teams. •Initial location: Indianapolis, IN Permanent location: Lilly Medicines Foundry, Lebanon, Indiana. Compensation: •$151,500 - $264,000 / year •Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance) 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!