Engineer - Downstream Technical Operations

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $167,200

This position is part of the Bioprocess Development (BR&D) organization. In this role you will be responsible for technical support of the downstream process for production of Bulk API in the K360 Clinical Trials Manufacturing Facility. The downstream process includes column chromatography operations, viral clearance operations, tangential flow filtration(s), depth filtrations, conjugation operations, and final API fill. You will work closely with development, operations, automation, and process engineering groups providing process and/or equipment technical oversight as required.

Several different processes run in the bioprocess pilot plant over the course of a year and each may be in a different stage of clinical development. The individual in this role provides technical oversight to the operations group of process streams leading to production of Bulk API for development and clinical trial purposes while maintaining compliance to current Good Manufacturing Practices (cGMPs).

Responsibilities:

• Plan downstream API material supply campaigns which includes generating a bill of materials and identifying the necessary equipment for the campaign

• Lead tech transfer discussions from process development scale to clinical supply scale

• Oversee scheduling of key tasks

• Identification and implementation of process or equipment changes and improvements

• Active process monitoring of ongoing campaigns

• Authoring of cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable

• Ensure processes/equipment are compliant with cGMP expectations where applicable

• Document studies in lab notebooks and author technical reports where applicable

• Troubleshoot and investigate production issues during Bulk API manufacturing campaigns as needed

• Active engagement and interaction with HSE, Quality Assurance, Process Engineering, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing

Basic Requirements:

• BS in chemical engineering, biochemistry, biological engineering, or related field

• Internship experience in the pharmaceutical industry OR 1+ year of experience post BS degree.

Additional Skills/Preferences:

• Background in GMP biopharmaceutical production environments

• 2+ years of experience in biopharmaceutical production unit operations supporting antibody or protein purification operations

• Understanding of process control systems

• Proficient in Unicorn method writing

• Problem solving skills

• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.

• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability.

Additional Information:

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

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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.

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