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. We’re looking for people who are determined to make life better for people around the world.
This position is responsible for providing process validation and technical writing support for the manufacture of monoclonal antibodies. This position will interact with Engineering, Manufacturing, Validation, Quality Assurance, Quality Control, Regulatory departments and other Lilly sites/contract producers as required. Knowledge of cell culture and/or purification and the support systems used in the manufacture of biotech products is required.
Plans, authors and executes process validation protocols and related studies. Educates self and others on complex issues and gains support for ideas.
Authors technical reports including but not limited to campaign summary reports.
Authors and reviews CMC sections of regulatory filings as needed
Authors technical sections of Annual Product Reviews (APRs).
Reviews protocols and technical reports, both within and external to TS/MS. Provides sound problem-solving skills to complex issues.
Collaborates with sample coordination to ensure required samples are processed and tested as required by the executed protocols, anticipating and resolving potential issues.
Authors standard operating procedures as they relate to activities of the TS/MS group
As required, may own or assist in the implementation of small to medium-scale projects or programs with with minimal to moderate risks and resource/financial requirements. Has impact within related departments or areas.
Requires business and technical knowledge within discipline and understanding key business drivers.
Makes decisions that impact a range of standard and non-standard operational, process, or project activities. Makes decisions within guidelines and policies.
11. Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as cGMP.
BS degree in Biochemistry, Chemistry, Microbiology or BS in Chemical Engineering.
Minimum of 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Excellent oral and written communication skills
Experience in fermentation/cell culture and/or protein purification manufacturing through education or past experience.
Process and equipment knowledge of cell culture and purification functions through education or past experience.
An understanding of current Good Manufacturing Practices required.
Process validation experience a plus
Demonstrated leadership skills
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.