Advisor/Senior Advisor â Purification Scientist/Engineer

4 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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. Weâre looking for people who are determined to make life better for people around the world.

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. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities by encouraging a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities to bring the next generation of life changing medicines to patients.

Our team is looking for experienced, creative, and upbeat candidates to conduct process design, development, and optimization of process scale chromatography development to support Lillyâs peptide, oligonucleotide, and conjugate portfolio. You would support the delivery of GMP clinical material to support clinical trials, while collaboratively developing the appropriate control strategies to support regulatory submission, transfer of process technology to manufacturing sites to enable product commercialization. The position presents the opportunity to work in a dynamic team comprised of purification scientists and engineers with close partnership to broader projects teams. Together the teams deliver solutions that advance our portfolio of potential medicines

Top candidates for this position will be encouraged to:

  • Work to design optimized downstream drug substance processes for new biosynthetic candidates. Possess working knowledge in chromatography process development, deploy a balance of first principles-based process modeling with carefully designed experiments 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.

  • Working knowledge of peptides and oligonucleotide separations.

  • 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, modeling, and simulation.

  • The ability to troubleshoot issues as they occur, and to identify trends and opportunities to reduce process variability.

  • 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 properly 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.

  • 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), and organizational skills.

  • Active participant in the external environment and the ability to recognize and apply external innovation and across the Lilly synthetic portfolio.

    Basic Qualifications:

    • Ph.D. in Chemistry, Chemical Engineering, or related field

    • M.S. in related field with 5+ years' experience in the pharmaceutical industry

    • B.S. in related field and 10+ years' experience in the pharmaceutical industry

      Additional Skills/Preferences:

      • Experience with chromatography process development

      • Experience with multivariate analysis to support process monitoring and troubleshooting at scale.

      • Experience with online and offline analytical techniques and process analytical technologies (PAT)

      • Good interpersonal skills and a sustained tendency for collaboration

      • Demonstrated initiative and risk-taking

      • Demonstrated technical proficiency and ability to create ideas for future work plans

      • Established external publication record

        Additional Information:

        • Travel: 0 to 10%

        • Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

          Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively âLillyâ) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

          Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

          Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Womenâs Network, Working and Living with Disabilities. Learn more about all of our groups.

          #WeAreLilly

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