Assoc Consultant Biologist-QC

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.

<p><b>Organization Overview:</b></p><p>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.</p><p><b>Position Brand Description:</b></p><p>The Associate Consultant Biologist for QC commercialization support commercialization activities for laboratories within Indianapolis Parenteral Manufacturing.  Responsibilities include method transfers, validations, or verifications of new molecules, collaboration with global analytical stewards, local change controls, and following Laboratory Quality Systems (LQS) and Global Quality Systems (GQS) for Parenteral QC.  Serve as a local data steward / laboratory key site contact for global site impacts.</p><p><b>Responsibilities:</b></p><ul><li>Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.</li><li>Champion for Site Impact Assessment for Compendial and GQS updates.</li><li>Act as local data steward / laboratory key site contact for new molecule implementation in the laboratory.</li><li>Lead / Supervise method transfers, validations, or verifications for new molecules in the laboratory.</li><li>Author technical documents to support commercialization, method transfers, validations or verifications, as applicable. Author change controls to support commercialization, new methods, new reference standards, etc.</li><li>Participate in APLOT and commercialization meetings.</li><li>Complete steps for global changes, as applicable.</li><li>Support global analytical stewards by gathering information on new methods.</li><li>Work closely with GQL and PR&amp;D to help guide and provide expectation was it relates to new methods.</li><li>Support audit activities.</li><li>Local technical SME for all micro methods</li><li>Method management for respective IPM Laboratories.</li><li>Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.</li><li>Perform technical training.</li><li>Coach lab analysts in real time.</li><li>Mentor analysts through formal process / program.</li><li>Review and approve change controls and deviations.</li><li>Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines.</li><li>Develop investigational testing protocols and perform testing as required.</li><li>Method validation / remediation.</li><li>Research and recommend new technologies.</li></ul><p><b>Basic Requirements:</b></p><ul><li>BSc or MSc in scientific or technical degree: chemistry, biology, engineering, or equivalent scientific / technical degree</li><li>20&#43; years of experience in a GMP QC laboratory and/or pharmaceutical industry</li><li>Demonstrated ability to lead projects</li><li>Experience supporting regulatory inspections</li><li>Strong influencing skills and interpersonal and teamwork skills</li><li>Both strong technical writing and communication skills</li><li>Strong self-management and organizational skills</li><li>Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Go