Job Description

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 39,000 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. Were looking for people who are determined to make life better for people around the world.

Organization Overview:
This position is responsible for the technical support of manufacturing operations. This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of Lilly products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Spreadsheet experience is required. Database experience a plus.

Responsibilities:

Responsible for supporting manufacturing operations through the performance of the following duties and representing TS/MS on Manufacturing Process Teams:

* Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Presents process data and analyses in Manufacturing Process Team meetings. Has impact within related departments or areas.

* Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Provides sound problem-solving skills to complex issues. Communicates issues in a timely manner. Leads process-related investigations and assesses technical impact. Educates self and others on complex issues and gains support for ideas.

* Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issues.

* Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.

* Writes standard operating procedures as they relate to the activities of the TS/MS group. Reviews and approves manufacturing batch records and other manufacturing documentation.

* Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.

* As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement small to medium continuous improvements to manufacturing processes.

* Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to implement control strategies for Lilly Branchburg processes.

* As required, may lead or assist in the planning and execution of process validation activities.

* As required, may own or assist in the implementation of small to medium process-related change controls with minimal to moderate risks and resource / financial requirements.

* Makes decisions within guidelines and policies.

* Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.

Basic Requirements:

* BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline.

* Experience in fermentation/cell culture and/or protein purification manufacturing.

* Process and equipment knowledge of cell culture or purification functions.

* Thorough understanding of GMP requirements for a large scale manufacturing facility.

* Excellent communication skills, both oral and written.

Additional Skills/Preferences:

* 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment.

* Process validation experience a plus.

* Demonstrated leadership skills.

Additional Information:

* Travel: <10%

* Branchburg, NJ

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.