Advisor, Manufacturing Quality Assurance - Lilly Medicine 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. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 e nvironmental impact.

As the Foundry is currently in design and construction (startup phase anticipated completion in 2027), the initial position will be fluid and dynamic as we endeavor to support the delivery of the Foundry, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing facility.

Once start up activities are completed, the   Flow   Mentor, Manufacturing   Quality   Assurance   function will   mentor   QA and cross-functional team members,   provide on-site quality oversight of GMP operations .

Responsibilities

Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.

Support cross-functional teams, facilitate decision making and drive progress.

Support the execution of the site operational readiness plan including development of early phase quality processes and operational procedures and controls.

Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.

Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.

Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.

Work cross-functionally with the plant teams to develop processes, provide operational support, and issue management.

Assist with inspection readiness activities.

Facilitate decision making within the team under tight deadlines.

Effectively communicate with internal and external stakeholders.

Participate in global communities of practice and committees, as appropriate, to establish and maintain a network for benchmarking and share learning.

Identify and lead process improvement projects impacting multiple business areas.

Basic Requirements:

BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.

Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

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: 

Experience in API   manufacturing   small and/or   large   molecules and/or high potent antibody drug conjugates (ADC).

Experience with applicable equipment cleaning requirements.

Relevant industry experience in high paced working environment.

Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

Demonstrated strong oral and written communication skills.

Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.

Flexibility to adjust quickly and effectively to frequent changes and altered priorities.

Ability to input and influence decision making for complex technical issues.

Ability to establish key relationships and influence peers and business partners.

Ability to identify and prioritize issues and develop & implement solutions.

High learning agility and ability to deal with ambiguity, uncertainty.

Demonstrated attention to detail

For Internal Lilly employees -LRL/Product Research Development experience preferred

Other Information:

Initial location at   Parkwood West, Indianapolis, Indiana.

Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Travel Percentage: 5% - 15%

May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$126,000 - $204,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly