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.

Position Brand Description:

This position provides leadership and strategic direction for the Parenteral Manufacturing Technical Services/Manufacturing Science (TS/MS) organization.

This includes management and governance of the technical agenda, support of the deviation and change control quality systems, ownership of operations batch records and applicable standard operating procedures, product/process monitoring, documenting, and maintaining product control strategies including risk assessments and documenting and maintaining the state of process/sterility assurance/cleaning validation.

Key Objectives / Deliverables:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Provide strategic direction to TS/MS organization
• Provide leadership and governance to the technical/scientific agenda for the site via the Science Lead Team (process monitoring)
• Represent the TS/MS organization at the Site Lead Team
• Develop administrative and technical leadership with the organization
• Assure that appropriately trained and qualified staff are in place to provide day to day support and project support for new and existing products
• Process monitoring for continuous improvement of control strategy, risk reduction, maintenance of the validated state and for manufacturing productivity
• Establish reward and recognition initiatives for staff
• Communicate effectively with Parenteral TS/MS Network Director and other Parenteral TS/MS leaders to ensure alignment of technical agenda and Central TS/MS initiatives for molecule, sterility, and components.
• Serve as a key technical resource for regulatory interactions
• Manage commercialization agenda in partnership with PR&D and central TS/MS.

Minimum Requirements:

• 10+ years of prior leadership experience leading in parenteral manufacturing technical services
• Demonstrated regulatory inspection experience interacting with regulators directly

Additional Preferences:

• Understanding of manufacturing and cGMPs
• Ability to prioritize efforts
• Effective written and oral communication skills
• Effective interpersonal skills
• Involvement in external pharmaceutical industry associations

Education Requirements:

• B.S. or equivalent in a scientific field of study

Other Information:

• Minimal travel required
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parental Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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), en Able (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

$241,500 - $354,200

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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