Scientist-TS/MS Full-time

Scientist-Ts/Ms

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.

The Scientist-TS/MS will provide direct technical support to the operations of the protein manufacturing process, being member of Process Team and reporting to Technical Service Manufacturing Science (TSMS) organization. Owner of the Operational Control Strategy and the Process Control Strategy including the Critical Process Parameters and Critical Quality Attributes (CQA's), and the historic and potential failure modes for the process and their associated countermeasures.

Job Responsibilities:

• Responsible for the definition and implementation of the routine process monitoring plan at the Process Team level and ensure that process monitoring plan is aligned with the Process Control Strategy and thus the process remains in control and capable.
• Primary responsible to proactively detect any change in process variability and identify/implement actions as response to it.
• Translate process requirements and educating Process Team and operators; design, review, and deliver Process School(s) at the beginning of each campaign or once per year.
• Document work and technical learning in official sources such as: Process Flow Diagrams (PFDs), laboratory notebooks, Quality Risk Assessments and technical reports.
• Participate in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises. Ensure process remains in a validated state via routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR).
• Responsible for carrying out investigations, identifying CAPA plans and presenting them to deviation board. Owner of change controls implementation which are expected to be completed in an effective and timely manner.
• Maintain an effective collaboration with secondary loop personnel, TSMS laboratory and/or pilot plant, other functions, and other Lilly manufacturing sites to identify best practices for replication.
• Ensure data integrity and verification procedures are followed. Document work and learning in official documentation systems such as; process flow documents, manufacturing instructions, SOPs, technical reports, etc.

Basic Requirements:

• Master's Degree in scientific disciplines of Chemistry, Biochemistry, Protein Chemistry, Microbiology, Analytical Chemistry or Engineering as minimum requirement. PhD is preferred.
• For applicants with master's degree at least 5 years of experience in protein manufacturing processes is required. Additional relevant industrial experience in any of the following associated disciplines such as, Engineering, Development, and Quality in Pharmaceutical or Protein Manufacturing Operations is desirable.
• For PhD applicants, academic experience in protein purification is required. At least one year of experience in protein manufacturing processes is preferred.
• Knowledge of cGMPs.
• Strong technical writing and presentation skills.
• Strong process data analysis using statistical tools.
• Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment.

• Fluency in English and Spanish (read/write) is required.
• Teamwork oriented
• Influence skills.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.
• Work with multiple assignments at a time and within an environment with distractions
• Proficient in Microsoft Office and JMP, and or Minitab.
• Availability to support 24/7 operations

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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. 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 $52,500 – $154,000.

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).