Lilly Senior Principal Research Associate 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 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.
The Senior Principal research Associate conducts routine and non-routine analyses and reviews analytical data of in-process materials, release, finished goods, validation and stability samples by appropriate bioanalytical methods. In this role, you will apply cGMP practices during execution of routine testing, design and perform method qualifications and validations per regulatory guidance, conduct investigations using scientific techniques, lead initiatives and project for team and department. Work independently and achieve problem resolution with minimal supervision.
Perform routine QC responsibilities such as:
Conduct routine and non-routine analyses and perform analytical data review of bioanalytical methods such as: PCR, ELISA, Cell Based Bioassay, etc.
Demonstrate initiative to lead routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed.
Design and perform method qualifications, validations and transfers per regulatory guidance.
Work independently with minimal supervisory guidance. Exhibit strong teamwork skills. Apply acceptable cGMP practices during execution of all work tasks.
Update supervisor of progress at scheduled intervals. Seek additional guidance as needed.
Use scientific expertise to provide assistance for troubleshooting, laboratory investigations and problem resolution. Lead troubleshooting and optimization of analytical methods. Conduct manufacturing investigations using various analytical techniques.
Perform independent assignments such as:
Conduct document reviews, author standard operating procedures (SOPs), and assay review.
Compile data and prepare graphs for documentation of test procedures and preparation of reports.
Provide scientific mentoring by sharing experience and knowledge of the product development process (analytical aspect in particular), disseminating technical knowledge and acting as a role model.
Suggest process improvements to QC management and lead process implementations. Uses external network with competitors/other industries to drive specific improvements to practices.
Provide influence on the responses to external regulatory guidelines and inspections.
If applicable, evaluate, coach, and manage personnel performance.
BS, MS or Ph.D. in a related scientific discipline such as Biology or Biochemistry.
Related experience in a pharmaceutical/biopharmaceutical manufacturing/laboratory environment: BS requires 8-10 years, MS requires 6-8 years and Ph.D. requires 4-6 years
Excellent working knowledge of cGMP regulation
Strong ability to troubleshoot and optimize analytical methods
Working knowledge of method qualification, validation and transfer.
Proven track record of scientific publications, invited presentations, or invention disclosures/patents. At least one first or senior authorship publication in a reputable peer reviewed journal.
Ability to provide scientific mentoring by sharing experience and knowledge.
Excellent teamwork, verbal and written communication skills. Attention to detail.
Ability to work independently. Achieve problem resolution using scientific rationale and with minimal supervision.
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!