Scientist

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.

Organization Overview:

The CT Manufacturing organization is responsible for the on time delivery of drug product for supporting clinical trials (Phase 1 through 4) as well as the associated technical information deliverables. This position is part of the Product Delivery (PD) organization to deliver the B358 clinical trial parenteral CT manufacturing plant.

The R1 position in Clinical Trial manufacturing encompasses technical knowledge and understanding of sterility assurance technologies and strategies employed within Clinical Trial Parenteral Manufacturing. The Scientist provides stewardship of the CT sterility assurance program, including assessment of and improvement of existing controls over time. The position also includes the knowledge of and improvement of environmental monitoring and cleaning/sanitization/gowning program supporting CT parenteral operations.

Primary Responsibilities:

• Provide leadership to daily EM laboratory operations and process/equipment qualification activities as necessary.
• Use of risk-based approaches to develop and aid in implement parenteral clinical trial manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Work with other EMSAT personnel to aid identification of aseptic manipulations and interventions and associated controls in parenteral processes and use of risk-based approaches to evaluate their acceptability.
• Provide on-site floor support to maintain cleaning program and provide guidance to operations, engineering, and quality assurance personnel.
• Support of sampling location selection in Environmental Monitoring Performance Qualification protocols and eventual identification of routine EM sampling sites.
• Perform site aseptic checks, as part of the self-inspection program including sharing of observations and recommendations to Operations and the Site Sterility Assurance Strategy Team.
• Participates in and/or provides consultation for investigation of sterility assurance and cleaning process related events and non-conformances.
• Represent / defend site sterility assurance strategies during internal assessments / audits and external regulatory inspections.
• Work with diverse on-site group in complex projects associated with sterility assurance strategies and/or executions
• Stays abreast of external regulatory requirements associated with sterility assurance, including active participation in relevant external technical forums (i.e. Parenteral Drug Association).
• Provides sterility assurance training for new hires and personnel from other sites.

Education Level/Experience:

• Minimum of a Degree in Microbiology, Biology or related scientific field (or equivalent work experience)

General Requirements:

• Excellent oral and written communication skills with the ability to interact well in a team environment.
• Excellent organizational skills with attention to detail.
• Strong computer skills and the ability to navigate electronic/computer systems with training
• Ability to respond to changing priorities and short lead times.
• Ability to clearly identify key issues in manufacturing process and work with teams to provide appropriate solution(s) to complex problems.
• Demonstrated ability to work independently and be a self-starter

Technical Requirements:

• Knowledge of cGMP's as related to CT manufacturing.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and PRD Goals.
• Experience in sterility assurance supporting a parenteral plant.
• Experience with parenteral product manufacturing preferred
• Understanding of GMPs and applicable internal standards
• Technical writing and presentation skills.
• Interpersonal skills including the demonstrated ability to effectively influence others including leadership.

Additional Information:

• Some domestic and/or international travel required.
• Some work outside of core hours may be required to enable the delivery of the portfolio

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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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.