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 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.
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.
Our products are targeted radioligands, a technology that holds significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the Lilly CORE team.
Position Summary:
The Scientist - QA team member provides daily on the floor oversight, assistance, and guidance to records such as non-conformance investigations, change controls, procedures, master batch record reviews, technical protocols/reports validations, batch disposition, commissioning, and qualification activities. Advise and provide floor support. This position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
Based in Indianapolis, Indiana and reporting to Associate Director, Quality Assurance, the position of Scientist, QA at POINT Biopharma/Lilly CORE is responsible for the following:
Responsibilities:
· Ensure regular presence in operational areas (preparation, formulation, filling and visual inspection, QC, warehouse etc. areas) as a part of QA on the Floor program to make sure facility is compliant with GMP and regulatory standards and inspection ready.
· Participate in facility QA walkthrough, identifying gaps and resolving with the area owner promptly. Escalate any critical issues to the QA Management in a timely manner.
· Lead, mentor, and coach operations and support personnel on quality matters.
· Review related batch records (inclusive of third-party batch review), analytical data and shipment data associated with parenteral manufacture, and final packaged product.
· Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
· Ability to assess and triage deviations / observations that occur within the local process team.
· Ability to effectively review and / or redline GMP documents to ensure quality attributes are met (i.e., deviations / observations, procedures, specifications, technical studies, validation protocols, change controls, and engineering documents).
· Effectively communicate with Associate Director - QA and other Quality Representatives on quality and operational issues.
· Participates in Six Sigma projects or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
· Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
· Work cross functionally and collaboratively with all levels of the organization.
· Foster positive demeanor, culture and professional attributes in alignment with Lilly CORE values.
· Perform any additional duties as required to support the business.
Accountabilities:
· Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
· Act as a cGMP liaison, working with project staff to complete the detailed design of the assigned areas employing QRM principals and ensuring the integration of Global Quality System requirements into the design.
· Actively participate in required design reviews and final design qualification activities.
· Provide technical and quality review and approval of project documents to ensure compliance with POINT Quality Standards as well as project and local quality procedures
· Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas.
· Support the organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff.
· Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
· Support the execution of inspection readiness activities including support of site self- inspections.
· Lead project initiatives needed in support of the project and Quality function
· Resolve or escalate any compliance issues to the project, site, and Quality Management.
· Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
Basic Requirements:
· Bachelor's degree in a science field and/or relevant working experience.
· Minimum 3 years working in the pharmaceutical manufacturing industry preferably in Quality Assurance roles.
Additional Preferences:
· An excellent understanding and knowledge of Microsoft office products - Word, Excel, and PowerPoint.
· Experience with electronic data systems is a plus.
· Experience creating and editing in multiple file systems.
· Excellent oral and written communication skills.
· Ability to work and adjust to a changing environment.
· Demonstrated ability to function well in a collaborative team environment.
· Ability to plan, develop and execute multiple projects under tight timelines.
· Operate and execute with an extreme sense of urgency.
· Excellent organizational and interpersonal skills.
· Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel).
· Manage multiple projects, set priorities, and work in a fast-paced environment.
Additional Information:
· Ability to work 8-12 hour shifts onsite (not eligible for remote work)
· Ability to work overtime and weekends as required
· May be required to respond to operational issues outside of core business hours / days.
· Applicant may work in various areas within the radiopharmaceutical plant following safety guidelines. Exposure to radiation should be considered when applying for this position.
Physical Demands/Travel:
The physical demands of this job are consistent with a manufacturing environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in a combination of Manufacturing Floor and Office environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Lilly currently anticipates that the base salary for this position could range from between $63,000 to $162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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