Associate Director TSMS

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 123,000 - 180,400; Full time

Benefits offered by this job

Comprehensive benefits program

Eligibility for a company bonus

401(k) and pension plans

Job summary

Initial Therapeutics, Inc. is seeking a qualified individual to lead a team of scientists focusing on technical excellence and compliance in cGMP commercial API manufacturing. The role involves overseeing document reviews, managing staff, and implementing data analytics tools to enhance process performance.

Ideal candidates will have advanced degrees in relevant fields and extensive experience in manufacturing environments. Strong leadership and project management skills are crucial for this position, coupled with a proactive approach to influence regulatory and business objectives.

Qualifications

• 6+ years (B.S./M.S.) or 5+ years (Ph.D.) of relevant cGMP commercial API manufacturing experience.
• Hands-on experience with digitalization initiatives.
• Strategic thinking and ability to balance short‑term needs with long‑term business evolution.

Responsibilities

• Ensure technical review and approval for documents.
• Hire, manage, mentor, and develop a team of scientists.
• Champion the adoption and integration of data analytics platforms.

Skills

Team leadership

Digitalization initiatives

Project Management

Analytical skills

Education

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

Tools

Manufacturing execution systems (MES)

Data historian platforms (e.g., OSIsoft PI)

Job description

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.

For individuals with disabilities who require accommodation in submitting 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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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400. 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.