Sr. Principal Associate Analytical Quality Assurance - Foundry

Position: Sr. Principal Associate for Analytical Quality Assurance - Foundry
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.

Overview:

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 and

Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Sr. Principal Associate for Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners are carried out in accordance with global and site quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation, reporting, and maintenance of analytical data.

As the Foundry is currently in design and construction, this position will provide Quality oversight for the detailed design and quality processes related to GMP testing and analytical development as well as qualification support for analytical methods and instrumentation. The position is responsible for ensuring that the quality management system is established and adhered to for this area.

Responsibilities

* Provide quality oversight in Analytical testing, namely: molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records).

* Provide quality oversight of method verification, qualification, and validation activities.

* Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.

* When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data.

* Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.

* Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.

* Be available for consultation on quality-related issues as needed.

* Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices.

* Promote a positive quality culture and oversee quality presence in the respective laboratory areas.

* Identify and lead process improvement projects impacting multiple business areas.

Basic Requirements:

* Bachelor's degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience. Quality assurance experience in the pharmaceutical industry, preferred.

* Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.

* Strong knowledge of analytical method development and validation.

* Strong knowledge of the current GMP expectations and application of quality management systems in execution.

* Minimum 5 yrs of experience in laboratories and analytical testing.

* 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

* Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.

* Ability to provide input and influence decision making for…