All Of Our Groups
healthcare
AssociateDirector–QC–IAPIAnalyticalSciences
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“Associate Director – QC – IAPI Analytical Sciences at All Of Our Groups. Skills: analytical sciences, Quality Control, method development, analytical control strategy. leading the Indianapolis API QC Analytical Sciences team. establishing key capabilities needed to support site operations, QC, and commercialization work within IAPI”
What You'll Achieve.
ensure site competencies in fields including but not limited to analytical stewardship, chromatography, Mass Spectroscopy, and Process Analytical Technology; ensure the analytical control strategy from raw materials through drug substance is technically sound, cost effective, compliant and sustainable for specific molecules; ensure inspection readiness
Industry & Context.
critical decision making; problem-solving skills; troubleshooting; investigation of major analytical issues
On-site presence required, Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role
What They're Looking For.
Must Have
Bachelor’s degree in a science field related to the laboratory (e. g. , chemistry, microbiology or biology), 5 years of relevant experience in a cGMP lab, 2+ years supervisory experience, Demonstrated data analysis and documentation skills, Demonstrated attention to detail, critical decision making, and problem-solving skills, Demonstrated oral and written communication and interpersonal interaction skills, Knowledge of cGMPs and quality systems, Authorized to work in the United States on a full-time basis
Nice to Have
Experience in method development and validation, Experience with a broad range of analytical techniques, Knowledge of ICH guidelines applicable to analytical sciences, statistical skills
What You'll Do.
leading the Indianapolis API QC Analytical Sciences team
establishing key capabilities needed to support site operations
and commercialization work within IAPI
providing stewardship of the analytical control strategy
influencing the analytical control strategy from late stage development to commercialization
providing leadership and oversight for method development and transfers
driving improvement of the analytical control strategy
continuous optimization of methods leveraged in the laboratory
continued modernization of equipment and processes used within the laboratory
identifying and supporting the implementation of new technologies/methods
prioritizing analytical initiatives based on business impact and risk analysis
providing resources and oversight to ensure the analytical control strategy is technically sound
compliant and sustainable
providing resources and oversight for the troubleshooting and investigation of major analytical issues
supporting global Analytical Quality Control Organization initiatives
reviewing and/or approving documents
supporting regulatory inspections
developing and implementing technical coaching and mentoring strategy
How You'll Work.
Team & Collaboration
cross-functional collaboration with TS/MS and PAT; collaborate with site operations and TS/MS
Communication Scope
oral and written communication; interpersonal interaction
Process & Methodology
Prioritize analytical initiatives based on business impact and risk analysis
Full Job Description
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. **_Position Brand Description:_** The Indianapolis API site has a long legacy of operating with technical excellence while producing lifesaving medicines for many decades. We are currently executing a complex modernization and transformation effort across the site that includes a strong analytical agenda. We are seeking a talented individual that can provide technical leadership and mentoring to drive analytical initiatives and improvements. The Quality Control (QC) Associate Director (AD) Analytical Sciences is responsible for leading the Indianapolis API QC Analytical Sciences team by establishing key capabilities needed to support site operations, QC, and commercialization work within IAPI. The Analytical Sciences team provides stewardship of the analytical control strategy. The position also influences the analytical control strategy from late stage development to commercialization. This role requires cross-functional collaboration with TS/MS and PAT to support site and network initiatives. **_Key Objectives/Deliverables:_** * Uphold company values of Integrity, Excellence, and Respect for People. * Ensure employees maintain required training and adhere to company policies and guidelines. * Recruit and manage team members’ performance. * Develop and execute a comprehensive technical capability strategy to ensure site competencies in fields including but not limited to analytical stewardship, chromatography, Mass Spectrosco
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