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 35,000 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:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Responsibilities :
The Responsible Scientist performs holistic data reviews, interprets results, and releases data for the QC Laboratories. The Responsible Scientist utilizes their experience and technical skills to assist laboratory analysts with problem solving and leads critical investigations, including for Out of Specification Results.
The Responsible Scientist may lead and perform lab work for commercialization and technical agenda projects such as method validations, qualifications, method transfers, and equipment evaluation and qualification. The position is responsible for the technical mentoring of lab staff and sharing of technical information and best practices within the work group and across network laboratories.Key Objectives/Deliverables:
Basic Qualifications :
- Perform in-depth second tier holistic review including data integrity and technical assessment of all analytical testing associated with the batch, stability, reference standard characterization, and production testing support prior to the release of individual test data and issuance of CoT.
- Performs periodic evaluation of method performance within the lab.
- Contributes to Annual Product Reviews as required.
- Interacts effectively with business partners to communicate and resolve issues. Understands business requirements of the other functions. Participates as an ad-hoc member of process teams
- Perform mentoring, coaching, and technical training of laboratory analysts.
- Review and approve change controls, investigations, observations, and deviations.
- Review and interpret data, and document results and conclusions in technical reports.
- Work with Regulatory Affairs to provide information and data supporting regulatory submissions. Writes and publishes technical reports and memos.
- Leads or performs investigations of aberrant data, OOS, and OOT results. Performs root cause analysis and draws conclusions. Recommends solutions to prevent reoccurrence.
- Authors investigational testing protocols and performs testing as needed.
- Supports management in ensuring that all laboratory operations are in compliance with global and local procedures, and the laboratories are inspection ready at all times.
- Provide direct support for laboratory inspections.
- Define and maintain inspection readiness activities
- Interact with regulatory agencies during GMP inspections as appropriate
Additional Skills/Preferences :
- Combination of education, training and previous technical experience in a biopharmaceutical or similarly regulated GMP laboratory that provides the knowledge, skills, and abilities to perform the job:
- Bachelors degree requires 10+ years experience
- Masters degree requires 8+ years experience
- PhD requires 7+ years experience
- Microbiology laboratory experience required
- Experience with a broad range of analytical techniques applicable to monoclonal antibodies
- Knowledge of ICH guidelines applicable to biotech drug substance
- Strong statistical skills
- Demonstrated flexibility and change agent
- Strong problem-solving skills with experience in Root Cause Analysis.
- Superior written and verbal communication skills
- Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbial assays
- Strong quality and safety mindset
- Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations
- Deep understanding of compliance requirements and regulatory expectations
- Demonstrated accuracy and proficiency in analytical skills
- Strong oral and written communication skills
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).