Advisor/Senior Advisor, Purification Development

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

The Bioproduct Research and Development organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, scientists have full access to our scientific excellence and engineering capabilities. Do you enjoy downstream drug substance processes including purifying and filtering monoclonal antibodies, recombinant proteins, viral vectors, bioconjugates and peptides? Do you have experience with process development and tech transfer? Are you skilled in the analytical techniques used to characterize bioproducts? If so, then a role as a Purification Development Scientist is waiting for you. This role requires a strong scientific foundation, effective interaction and communication of technical information with, but not limited to, Safety, Environmental and Quality Team members, Purification Development colleagues, CMC Team members, Discovery team members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel. Especially important, in this role, is that you adhere to all safety and environmental guidelines and promote a proactive safety culture and environmental compliance in all areas.

Requirements

• PhD in Chemical Engineering or related degree focused on biological separation sciences OR MS in Chemistry, Chemical Engineering, or related degree with at least 5 years relevant experience in leading protein purification/process development OR BS in Chemistry, Chemical Engineering, or related degree with at least 8 years relevant experience in leading protein purification/process development

Nice To Haves

• Ability to exhibit a high level of attention to detail, a quality-minded approach to experimental design and record keeping.
• Effective oral and written communication skills
• Strong laboratory skills
• Experience purifying complex bioconjugates (e.g., ADCs, PEGylated proteins, antibody-oligonucleotide conjugates).
• Purification development experience with AAV, mRNA, or other gene therapy strategies.
• Extensive knowledge of membrane filtration
• Ability to interact and form dynamic relationships with a wide range of groups.
• Experience with process control and documentation systems (Unicorn, Empower, electronic laboratory notebooks).
• General interpersonal and communication skills; mentoring, feedback, training, and cultivating an environment for learning and open/honest communication.
• Basic analytical skills and understanding
• Advanced problem-solving skills
• Experience interfacing with CDMOs or external development partners
• Experience supporting late-phase process development activities, such as risk assessment, process characterization, or regulatory filing

Responsibilities

• Identify and develop new purification technologies.
• Design optimized downstream drug substance processes for new biologic candidates.
• Maintain accurate records and interpret data to provide detailed information and analysis on the execution of experiments.
• Employ strategic thinking to overcome technical hurdles and oversee process and technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic.
• Write technical reports, tech transfer documents and give presentations to summarize development activities.
• Maintain flexibility to accept new projects and challenges.
• Troubleshoot issues as they occur and identify trends and opportunities to reduce process variability.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior