Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team
Company: Initial Therapeutics, Inc.
Location: Indianapolis
Posted on: June 1, 2025
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Job Description:
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 OverviewAt Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Position Brand Description:The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly's vision of serving more patients.Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration - and development of the local technical and operational teams to be ready for full operation.The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.Key Objectives/Deliverables:Responsible for the development, implementation and establishing ongoing monitoring of the Cleaning Program for new site facilities including but not limited to:
- Support new site TSMS cleaning teams on developing Cleaning
Validation Master Plan for the facility, using expertise and
benchmarking from other sites.
- Develop a standard and clear procedure for conducting a
Cleaning Assessment and train relevant personnel on how to
implement and maintain.
- Standardize Cleaning procedures and operating instructions -
ensure critical information is present and critical operating
parameters for effective cleaning are integrated into electronic
tickets.
- Standardize pre-start safety review for Cleaning and ensure
correct involvement of EHS, Engineering and Operations personnel.
- Ensure cleaning demonstration/validation protocols and reports
are standardized and technically correct.
- Develop appropriate metrics for Cleaning. Support site teams on
reporting metrics at Flow Team level.
- Improve efficiency on cleaning processes and identify projects
for improvement (e.g. activities that can run in parallel and those
that need to run in sequence).
- Engage on the development a training program/education for
TSMS, Process Engineering, QA and Ops based on the Cleaning Process
with site Cleaning team. Work on the roll out of communicating the
requirements of each step of the process and ensuring groups have a
holistic view of the process.
- During cleaning execution, provide support to the process teams
for cleaning activities ensuring all aspects of the flow are
coordinated appropriately. Attend and lead (if required) process
team meetings.
- Coordinate investigations related to cleaning. Trend events
across equipment trains and products and drive improvements.
- Drive improvements in the cleaning program based on external
benchmarking / industry trends.
- Transfer deep understanding of the GQS/Compliance requirements
associated with Cleaning.Basic Requirements:
- BSc Chemistry, Biochemistry or related science field with 8-10 years' experience in pharmaceutical manufacturing.
- MSc Chemistry, Biochemistry or science-related field with
minimum 5 years appropriate industry experience.Additional
Skills/Preferences:
- Deep technical interest and understanding of Cleaning within
Small Molecule, Peptide or Biotech.
- Excellent verbal and written communications skills
- Strong analytical and problem-solving skills
- Collaborative skills with operations, process engineering, QCL
and other process team members
- Technical knowledge of cleaning control
- Ability to coach others
- Ability to influence without authority
- Ability to clarify and simplify complex issues
- Strong trust building with peers and leaders
- Willing to work off-shift hours as needed to support project
milestones and training of new employeesOther Information:The ADN
RAMP team will support multiple new API/Dry Products sites in
various locations (US and OUS). Significant travel may be required
to current startup sites in order to meet business needs, along
with potential short-term assignments across the network (can
include international relocations). Candidates must be mobile and
flexible.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$64,500 - $167,200Full-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
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- Willing to work off-shift hours as needed to support project
milestones and training of new employeesOther Information:The ADN
RAMP team will support multiple new API/Dry Products sites in
various locations (US and OUS). Significant travel may be required
to current startup sites in order to meet business needs, along
with potential short-term assignments across the network (can
include international relocations). Candidates must be mobile and
flexible.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.
- Strong trust building with peers and leaders
- Ability to clarify and simplify complex issues
- Ability to influence without authority
- Ability to coach others
- Technical knowledge of cleaning control
- Collaborative skills with operations, process engineering, QCL
and other process team members
- Strong analytical and problem-solving skills
- Excellent verbal and written communications skills
- Deep technical interest and understanding of Cleaning within
Small Molecule, Peptide or Biotech.
- Transfer deep understanding of the GQS/Compliance requirements
associated with Cleaning.Basic Requirements:
- Drive improvements in the cleaning program based on external
benchmarking / industry trends.
- Coordinate investigations related to cleaning. Trend events
across equipment trains and products and drive improvements.
- During cleaning execution, provide support to the process teams
for cleaning activities ensuring all aspects of the flow are
coordinated appropriately. Attend and lead (if required) process
team meetings.
- Engage on the development a training program/education for
TSMS, Process Engineering, QA and Ops based on the Cleaning Process
with site Cleaning team. Work on the roll out of communicating the
requirements of each step of the process and ensuring groups have a
holistic view of the process.
- Improve efficiency on cleaning processes and identify projects
for improvement (e.g. activities that can run in parallel and those
that need to run in sequence).
- Develop appropriate metrics for Cleaning. Support site teams on
reporting metrics at Flow Team level.
- Ensure cleaning demonstration/validation protocols and reports
are standardized and technically correct.
- Standardize pre-start safety review for Cleaning and ensure
correct involvement of EHS, Engineering and Operations personnel.
- Standardize Cleaning procedures and operating instructions -
ensure critical information is present and critical operating
parameters for effective cleaning are integrated into electronic
tickets.
- Develop a standard and clear procedure for conducting a
Cleaning Assessment and train relevant personnel on how to
implement and maintain.
Keywords: Initial Therapeutics, Inc., Indianapolis , Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team, Other , Indianapolis, Indiana
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