Advisor

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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Description

The purpose of this position is to provide oversight and drive/maintain harmonization of technical programs that govern implementation and execution of Contamination Control Strategies (CCS) across the Lilly Lebanon API manufacturing site. This position will work closely with peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance and current expectations, as well as align with business needs. The successful applicant will build a deep technical expertise in their area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and continually monitoring the effectiveness of current strategies.

Responsibilities

The Advisor, CCS will represent the TS/MS function in the Lilly Lebanon API facility start up, ensuring integration with our manufacturing processes and product requirements.

• Assess differences in current CCS programs across the sites (internal and external) and drive harmonization at the Lilly Lebanon API Manufacturing site.

• Work closely with site and cross-functional SMEs to drive alignment. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Represent TS/MS across network governance forums and ensure that CCS programs are frequently presented to network team in order to achieve alignment across sites.
  • Ensure that learnings and best practices are shared across sites.
  • Set-up appropriate forums in order to share learnings and present case studies to site SMEs.
• Provide CCS technical support both for the initial start-up of the manufacturing areas as well as post Process Validation support.

• Understand and support global implementation of quality standards, best practices, and appropriate tools to ensure strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Engage in providing support during regulatory interactions including on-site inspections. Support regulatory submissions and site audits to ensure holistic assessment of CCS.

Microbiological Expertise:

• Ability to influence and communicate to diverse groups on complex regulatory, business, or technical CCS issues within the site and function.
• Provides foundational understanding of contamination control standards and strategies to support qualification of new flexible manufacturing facilities and processes.
• Understands the scientific principles required for manufacturing drug substance, including interaction of the chemistry, equipment, and contamination control strategies.
• Able to influence teams and build understanding of CCS functions across site.
• Works within cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and contamination control objectives.
• Ability to author, review, and/or approve technical documents, including personnel qualification strategies for technical staff, control strategies, investigations, change controls, expert opinions, qualifications, procedures, technical studies, etc.

Basic Requirements

• Minimum BS degree required in biological science or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical/Chemical/Biomedical Engineering, etc.).
• 10+ years experience including 5 years GMP experience
• Deep technical understanding of contamination control strategies, including regulatory expectations pertaining to all elements of contamination control: manufacturing facilities, production practices, equipment cleaning and validation, environmental monitoring, bioburden controls and other product protection control related systems.
• Strong knowledge of pharmaceutical manufacturing processes, facility start-up procedures, and GMP regulations.

Preferences

• Prefer 10+ years of progressively responsible experience directly supporting contamination controls within pharmaceutical manufacturing environment.
• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
• Strong analytical and quantitative problem-solving skills
• Experience in statistics
• Strategic thinking and ability to balance short term needs with long term business evolution
• Ability to mentor and develop scientists and engineers in contamination control principles, applications and applied pharmaceutical microbiology
• Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
• Demonstrated experience influencing site and network leaders to advance technical agenda projects

Additional information

• This is a fully on-site position located in Lebanon, IN
• This position could require some travel (including international), less than 10%
• This position is day shift, Monday-Friday, with off-hours support needed, by request

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 ( ) 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.