Position Overview:This position is part of the Bioprocess Development (BR&D) organization. The individual in this role will be responsible for technical support for production of drug substance (DS) in the K360 Clinical Trials Manufacturing Facility. They will interface with development, operations, automation, and maintenance groups providing process and/or equipment technical oversight as required.
Key Responsibilities: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 leading to production of drug substance (DS) for development and clinical trial purposes while maintaining compliance to current Good Manufacturing Practices (cGMPs). The individual in this role has the following responsibilities:
- Lead incoming and outgoing process tech transfers, including preparation of required tech transfer documents, production batch records, and required materials and consumables.
- Oversee scheduling of key tasks in operations Identification and implementation of process changes and process improvements.
- Ensure the appropriate health, safety and environmental assessments are completed during tech transfers
- Active process monitoring of ongoing campaigns or in process equipment
- Input or authoring for 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 and process excursions during DS manufacturing campaigns
- Active engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing
Basic Requirements:- Earned Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline
- 1+ year of hands-on experience in large molecule protein purification techniques (at pilot scale) and familiarity with protein purification principles
- Previous experience with tech transfers in a manufacturing environment
- Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
- Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management
- Strong problem-solving skills
Additional Skills/Preferences:- Background in GMP production environments
- Prior work in a biotech/pharmaceutical environment
- Proficient in DeltaV, PLCs, AKTA and/or Unicorn
- Understanding of computer system validation and equipment qualification
Additional Information:- Position located in Indianapolis, IN at the Lilly Technology Center North
- 8-hour days with flexibility to support production activities outside of working hours as needed, including occasional weekends
Work Environment:The physical demands of this job are consistent with a manufacturing environment
, and are representative of those that must be met by an employee to successfully perform the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$67,500 - $118,800
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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