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Advisor - Technical Services

Oversee downstream process transfer and validation for clinical biopharmaceutical production
Indianapolis, Indiana, United States
Senior
$129,000 – 209,000 USD / year
yesterday
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Lilly Bioproduct Research And Development Technical Lead

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.

This position is part of the Bioproduct Research and Development (BR&D) organization within Lilly Research Labs. The BRD Clinical Trial (CT) manufacturing facility is focused on bringing new protein therapeutics to market by producing bulk drug substance (DS) for clinical trials, along with the associated technical data and documentation to support GMP activities.

The Bioprocess Operations team within BR&D is responsible for the manufacture of DS to support clinical trials within the Lilly portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno-associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. This role serves as the Technical Lead for the Downstream Tech Service and Manufacturing Science (TS/MS) team within the BR&D DS CT manufacturing facility. You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, and acting as a key technical interface across development, operations, automation, and maintenance teams. In addition, you will mentor and develop downstream team members, fostering a culture of technical excellence and continuous improvement.

Responsibilities:

In this role, you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance plant performance and reliability. You will partner closely with cross-functional teams to resolve complex technical challenges, implement innovative solutions, and ensure seamless integration of development-stage technologies into clinical manufacturing. Your leadership will extend beyond technical execution to include coaching and developing talent within the team. Responsibilities will include:

Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing

Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable

Ensure robust execution of DS batches with adherence to quality and regulatory standards

Active oversight of process and equipment performance, troubleshooting, optimization and real-time data monitoring

Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant

Drive alignment between process development and manufacturing execution

Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations

Actively engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges.

Coach and mentor team, fostering technical growth and professional development

Promote a culture of collaboration, accountability, and operational excellence

Basic Requirements:

PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience OR

MS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 5 years hands-on purification experience OR

BS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 8 years hands-on purification experience

Proficiency with UNICORN software for chromatography process control and data analysis

Demonstrated ability to lead cross-functional projects and mentor technical staff

Excellent communication and leadership skills, with the ability to influence and drive change

Additional Preferences:

Understanding of cGMP requirements and regulatory compliance for clinical manufacturing

Experience with scale-up of biopharmaceutical purification operations

Familiarity with automation systems and process control strategies

Understanding of computer system validation and equipment qualification

Familiarity and strong interest in application of digital solutions for GMP DS manufacturing

Position located in Indianapolis, IN at the Lilly Technology Center North

8-hour days with flexibility to support activities during shutdowns, weekends, and outside of core hours

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $209,000.

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Advisor - Technical Services
Indianapolis, Indiana, United States
$129,000 – 209,000 USD / year
Support
About USA Jobs
Provides a centralized online platform for searching and applying to employment opportunities across the United States.