Director-Analytical Development and 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.

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 35,000 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 Avid group's mission is to discover, develop, and deliver diagnostic solutions that improve global health by accelerating the development of new medicines. Avid's diagnostic solutions aid in early diagnosis, monitor the treatment effect of therapeutics and help understand disease pathology better. Avid is leveraging the power of diagnostics to transform patient outcomes. Avid is committed to accelerating the next generation of diagnostic tools to understand and unlock the potential of emerging science, enables the discovery of new medicines, and advance care for patients with unmet needs.

Position Overview:

The Director, Analytical Development and Quality Control (AD/QC) is responsible for managing the development and validation of phase-appropriate methods for radiopharmaceutical imaging agents throughout the development phases. This position requires a strong technical background in analytical methods and compliance with CGMP regulations, ensuring the integrity of products from preclinical through commercialization of a product. This position will be responsible for management of direct reports and ensure individual accountability to objectives/business goals and support their growth and development.

Key Responsibilities:

* Manage the development and validation of phase-appropriate (pre-clinical through commercial) analytical methods to applicable global standards that are suitable for internal and external (CRO / CMO) implementation for assay, purity and dissolution methodologies; compendial methods verification; identification of impurity and degradation products; reference standard qualification, and physical (solid-state) characterization

* Develop phase-appropriate specifications and quality control strategy for drug substance and drug product.

* Develop and manage phase-appropriate drug substance and drug product stability study programs and ensure retest and expirations dates can support clinical development and regulatory objectives & timelines

* Maintain oversight of precursor and reference standard AD/QC activities at CMOs including planning, coordinating, and management of routine testing and associated stability programs at CMOs

* Manage analytical method technology transfer to CMOs

* Review / QC batch record analytical data packages

* Support troubleshooting analytical issues and OOS investigations with CRO/CDMO

* Manage and provide guidance on outsourced studies, timely receipt of quality test data and other relevant documentation, and preparation of final study reports

* Author and/or review analytical development, validation and stability reports and analytical sections in global regulatory dossiers and support responses to information requests from health authorities.

* Present project progress including critical needs/issues at project meetings

* Participate in initiatives for improving functional processes and technical operations within CMC

* Manage day-to-day operations of AD/QC labs and AD/QC team and ensure compliance with cGMP regulations, SOPs and HSE procedures. Ensure readiness of AD/QC labs for inspections by regulatory agencies, quality assurance and HSE.

* Develop, motivate, and retain high-performing team by providing relevant performance goals, delegating appropriately, empowering team members to take initiative, and coaching team members in their development

* Lead decision-making and problem-solving processes within the team

* Maintain proficiency with applicable and current global cGMP regulations and industry standards and trends

Required

Experience and Skills:

* A BS degree in chemistry or a related field with at least 15 years of experience in industrial pharmaceutical analytical development/QC or an advanced degree with 10+ years of experience

* 10 years' experience in lab management

* Demonstrated advanced understanding of cGMPs, ICH Quality guidance, FDA CMC guidance

* Demonstrated ability to…