Lilly Principal Research Scientist-QC Microbiology in Branchburg, New Jersey
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. We’re looking for people who are determined to make life better for people around the world.
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.
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.
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
Basic Qualifications :
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
Additional Skills/Preferences :
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
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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).