Sr. Principal Associate for Analytical Quality Assurance - Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

About the role

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, including 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.
• Evaluate potential impact of incidents on quality of materials or the integrity of data when necessary.
• 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.

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 years of experience in laboratories and analytical testing.
• 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.

Skills

• Ability to manage in a dynamic environment with flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Ability to provide input and influence decision making for complex technical issues.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Experience with networking across industry, such as with industry groups or committees.
• Success in coaching and mentorship.
• Ability to establish key relationships and influence peers and business partners.
• Strong communication skills.
• Ability to identify and prioritize issues, develop, and implement solutions.
• High learning agility and ability to deal with ambiguity and uncertainty.
• Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis.

Location

Initial location at Parkwood West, Carmel, Indiana. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).