Director, Purification Process Development

Our team is looking for experienced, creative, and energetic candidates to lead process design, development & optimization of process scale chromatography development to support Lilly’s peptide, oligonucleotide, and conjugate portfolio. The candidate would support the delivery of GMP clinical material to support clinical trials, while developing the appropriate control strategies to support regulatory submission, transfer of process technology to manufacturing for product commercialization. The position presents an opportunity to lead dynamic teams comprised of purification engineers and closely partner with purification scientists and broader project teams to deliver solutions that advance the portfolio of potential medicines. Responsibilities Work to design optimized downstream drug substance processes for new biosynthetic candidates. Possess fluent knowledge in chromatography process development, deploy a combination of first principles-based knowledge and experimentation for process design and optimization, possess strong process equipment knowledge, and expertise in scale‑up methodologies with a drive to challenge existing methods; create and apply cutting edge technology and novel platforms within a time‑constrained environment. Familiarity and working knowledge of peptides and oligonucleotide separations. Employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities. Demonstrate high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities. Develop and deploy modern technologies, including continuous processing, automated screening methods, PAT, and modeling and simulation. Ability to interface across multiple projects to understand various business needs. Continue to build the purification engineering team to critical mass. Comfortable with scientific uncertainty and the ability to translate hypotheses into action. Supervise, mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. Encourage team members to take initiative and accountability to achieve goals; draws out and encourages others to share knowledge. The ability to troubleshoot issues as they occur, and to identify trends and opportunities to reduce process variability, are also key. Provide technical guidance in the scale‑up and demonstration of new purification processes in development and commercial scale equipment. Participate in technology transfer activities to CRO/CMO organizations and Lilly manufacturing to ensure processes are technically sound, well developed and characterized, and safe. Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Ability to generate process (and property design) data based on a fundamental understanding of the underlying physical processes. Utilize advancements in technology (PAT) and modeling platforms to understand and direct experimental protocols. Plan and manage short term and long‑term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. Collaborate with internal and external manufacturing partners to develop robust processes that are readily amenable to efficient drug substance manufacturing. Collaborate closely with Project teams including Project Management, Quality, Manufacturing, and Regulatory scientists to execute and deliver material and information for clinical trials and regulatory submissions. Embrace diverse thought, background, and experience to deliver innovative solutions. Possess strong communication (oral, written), organizational, and leadership skills. Active participant in the external environment and the ability to recognize and apply external innovation and across the Lilly synthetic portfolio. Possess deep understanding of the external global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications. Minimum Qualifications Ph.D. in chemical engineering, chemistry, or a closely related field with 5+ years of experience OR MS Degree with 10+ years of experience OR BS Degree with 12+ years of experience. Experience within the pharmaceutical sector. Experience with developing purification processes from mid‑development cycle (proof of concept) to product commercialization. Experience with technical transfer of processes into manufacturing operations. Additional Skills/Preferences Experience with authoring regulatory submissions and responding to regulatory questions. Experience with multivariate analysis to support process monitoring and troubleshooting at scale. Travel: 0 to 10% Position Location: Indianapolis, IN; Lilly Technology Center‑North (LTC‑N). Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #J-18808-Ljbffr