BioSpace
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Senior Director - API Operations
role at
BioSpace .
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, 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 the production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Position Overview
The
Senior Director, Operations
is responsible for leading manufacturing operations—either small molecule or siRNA/oligonucleotide—ensuring the organization has the capacity, capability, and leadership to deliver the site’s manufacturing plan. This role also integrates cross‑functional support teams and fosters a strong safety culture.
As a member of the
Lilly Site Lead Team , the Senior Director contributes to strategic direction, organizational development, and cross‑functional issue resolution.
During the
project delivery and startup phase (2029–2030) , the role will focus on:
Supporting facility delivery and operational readiness.
Building the manufacturing organization and leadership structure.
Developing and implementing GMP systems and processes.
Shaping site culture and ensuring alignment with long‑term business goals.
Responsibilities
Pre‑Startup and Startup Phase:
Lead collaboratively and energetically across all aspects of operational readiness and startup.
Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence.
Develop and implement site systems and processes, drawing on internal expertise and external best practices.
Embed lean principles and a continuous improvement mindset across operations and support functions.
Act as the end‑user representative during project delivery—providing input on design, commissioning, and startup decisions to ensure alignment with project goals and long‑term strategy.
Post Startup:
Develop and execute strategic and operational plans for Production Operations.
Contribute to the site’s medium‑ and long‑term strategic direction.
Ensure compliance with all applicable regulatory requirements (e.g., safety, quality/cGMP, environmental, financial, legal, HR).
Ensure Production Flow and Process Teams meet Lilly’s Manufacturing Standards for Operational Excellence.
Maintain robust control systems to manage operations, identify compliance risks, and elevate issues appropriately.
Monitor site and business area performance and take corrective action as needed.
Lead cross‑functional teams to implement new product introductions and continuous improvement initiatives.
Develop future management and technical leaders for site and global roles.
Requirements
Bachelor’s degree in a relevant discipline.
10+ years of experience leading operations within the pharmaceutical industry.
Additional Preferences
Experience in API manufacturing and Process Safety Management preferred.
Strong knowledge of cGMPs and their application in manufacturing operations.
Proven ability to build effective relationships across all organizational levels, including close collaboration with the Site Leadership Team.
Demonstrated success in leading projects from initiation to completion—on time, within budget, and to high performance standards.
Skilled in developing and managing high‑performing, engaged teams with a strong safety and team‑oriented culture.
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.
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Senior Director - API Operations
role at
BioSpace .
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, 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 the production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Position Overview
The
Senior Director, Operations
is responsible for leading manufacturing operations—either small molecule or siRNA/oligonucleotide—ensuring the organization has the capacity, capability, and leadership to deliver the site’s manufacturing plan. This role also integrates cross‑functional support teams and fosters a strong safety culture.
As a member of the
Lilly Site Lead Team , the Senior Director contributes to strategic direction, organizational development, and cross‑functional issue resolution.
During the
project delivery and startup phase (2029–2030) , the role will focus on:
Supporting facility delivery and operational readiness.
Building the manufacturing organization and leadership structure.
Developing and implementing GMP systems and processes.
Shaping site culture and ensuring alignment with long‑term business goals.
Responsibilities
Pre‑Startup and Startup Phase:
Lead collaboratively and energetically across all aspects of operational readiness and startup.
Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence.
Develop and implement site systems and processes, drawing on internal expertise and external best practices.
Embed lean principles and a continuous improvement mindset across operations and support functions.
Act as the end‑user representative during project delivery—providing input on design, commissioning, and startup decisions to ensure alignment with project goals and long‑term strategy.
Post Startup:
Develop and execute strategic and operational plans for Production Operations.
Contribute to the site’s medium‑ and long‑term strategic direction.
Ensure compliance with all applicable regulatory requirements (e.g., safety, quality/cGMP, environmental, financial, legal, HR).
Ensure Production Flow and Process Teams meet Lilly’s Manufacturing Standards for Operational Excellence.
Maintain robust control systems to manage operations, identify compliance risks, and elevate issues appropriately.
Monitor site and business area performance and take corrective action as needed.
Lead cross‑functional teams to implement new product introductions and continuous improvement initiatives.
Develop future management and technical leaders for site and global roles.
Requirements
Bachelor’s degree in a relevant discipline.
10+ years of experience leading operations within the pharmaceutical industry.
Additional Preferences
Experience in API manufacturing and Process Safety Management preferred.
Strong knowledge of cGMPs and their application in manufacturing operations.
Proven ability to build effective relationships across all organizational levels, including close collaboration with the Site Leadership Team.
Demonstrated success in leading projects from initiation to completion—on time, within budget, and to high performance standards.
Skilled in developing and managing high‑performing, engaged teams with a strong safety and team‑oriented culture.
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.
#J-18808-Ljbffr