Associate Director Validation Jobs in Indiana (NOW HIRING)

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 Overview

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

The Associate Director – Technical Services / Manufacturing Science (TSMS) – API is responsible for providing technical and people leadership across Active Pharmaceutical Ingredient (API) manufacturing processes supporting cGMP commercial and late-phase operations. This role oversees the full lifecycle of technical activities including technology transfer, process validation, manufacturing support, process optimization, and lifecycle management of API products.

The Associate Director is expected to lead by example, coaching and developing a team of scientists and technical staff while driving a strong safety and quality culture. A key differentiator for this role is the ability to leverage data analytics and digitalization strategies to enhance process understanding, improve manufacturing performance, and advance site capabilities.

This position requires close collaboration with Engineering, Operations, Quality Assurance, Quality Control, Regulatory Affairs, and Development functions to deliver on the site's technical agenda in a highly cross-functional environment.

Responsibilities

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.

• Hire, manage, mentor, and develop a team of scientists and technical staff, fostering a culture of excellence, accountability, and continuous learning.

• Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives

• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits

• Ensure adequate oversight and technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, and quality.

• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.

• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.

• Champion the adoption and integration of data analytics platforms, statistical process control (SPC), and real-time monitoring tools to improve process performance and reduce variability.

• Partner with Digital/IT and Engineering functions to define and implement a site digitalization roadmap aligned with business and quality objectives.

• Drive digitalization initiatives including manufacturing execution systems (MES), digital execution, data historians, and advanced analytics dashboards to enable data-driven decision-making.

Basic Qualifications:

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences.

• 6+ years (B.S./M.S.) or 5+ years (Ph.D.) of relevant cGMP commercial API manufacturing experience in TSMS or associated disciplines such as Manufacturing, Quality Assurance, Quality Control, Engineering, or Regulatory Sciences.

Additional Preferences:

• Responsible for maintaining a safe work environment

• Ability to influence and lead diverse groups

• Influences complex regulatory, business, or technical issues within the site and function

• Hands-on experience with digitalization initiatives including MES implementation, data historian platforms (e.g., OSIsoft PI), digital execution platforms, or LIMS systems.

• Track record of leading or contributing to continuous improvement programs leveraging digital tools and data analytics.

• Technical leadership, administrative and organizational skills

• Builds relationships with internal and external customers and partners

• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional

• Demonstrated Project Management skills and ability to coordinate complex projects

• Strong analytical and quantitative problem-solving skills

• Ability to communicate and influence effectively across functional groups and stakeholders

• Strategic thinking and ability to balance short term needs with long term business evolution

• Enthusiasm for changes, team spirit and flexibility

Additional Information:

• Minimal travel (<10%) may be required

• Some off-shift work (night/weekend) may be required to support 24/7 operations

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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.

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