Director, Purification Process Development

Eli Lilly and Company•Us, IN

8h•Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients. 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 projects teams to deliver solutions that advance the portfolio of potential medicines. Top candidates for this position will be expected to: 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

Requirements

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

Nice To Haves

Experience with authoring regulatory submissions and responding to regulatory questions
Experience with multivariate analysis to support process monitoring and troubleshooting at scale.

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

Benefits

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).

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