Director Quality Control Chemical Device and Incoming Testing Laboratories
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.
Eli Lilly and Company is seeking a Director Quality Control Chemical, Device and Incoming Testing Laboratories to join our team in Indianapolis, Indiana.
Director Quality Control Chemical, Device and Incoming Testing Laboratories - 52462BR
Responsible for the oversight and execution of the product testing; in particular all Chemical test for raw materials, in-process samples, semi-finished and finished products, physical and functional testing of Drug/Device combination product and visual and physical testing of packaging components. Responsible for providing administrative and technical leadership to the Quality Control Laboratories. Responsible for ensuring there is an adequate quality system in place for material and product testing, including instructions and procedures to execute the testing, that testing equipment and instruments are qualified, and personnel trained. Responsible for the resourcing of the quality control unit and the continuous professional development of the quality control team. Serve as a Site/Plant agent to manage compliance to all cGMP, procedures, policies, and guidelines, and support development of the business plan. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; participate on the plant lead team and Parenteral Quality Lead Team. Serve as a conduit for Corporate communications; exhibit critical business decision making bringing about successful results. Develop plan for capital purchases and manage department budget. Provide technical support and expertise for site and Corporate on analytical topics. Provide leadership for complex analytical investigations and matters, in particular for biotechnological products (proteins and peptides). Act as quality control and analytical representative in cross-functional teams investigating technical issues, method development/changes and adjustments and lead data interpretation and conclusions/recommendations. Lead analytical investigations related to out of specifications/out of trend (OOS/OOT). Position supervises 9 individuals (include three Manager QCs, one QC Sr. Assistant, one QC Associate Sr. Consultant, and four QC Consultants) with a total team of 86.
Employer requires a PhD in Chemistry, Protein Chemistry, or related field, and 8 years of related experience.
Work experience must have included:
International experience in a quality control related field
8 years of experience in GMP manufacturing environment
Management of large scale GMP manufacturing operations
Interacting with regulatory agencies
Understanding compliance requirements and regulatory expectations relating to material and product testing and experience in commercialization support, method validation, method transfer and improvement methods (e.g. Lean Laboratory program)
Experience in technical field within pharmaceutical manufacturing of Biotechnology products (proteins).
Position is located at 1555 S Harding St, Indianapolis, IN 46221
Full time (40 hours/week)
Travel Required: Up to 15% international and domestic travel required to represent the site & Lilly at the network level or to support other sites or contracted labs in critical issues.
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.