Senior Director - Parenteral Operations

BioSpace; Pleasant Prairie (WI); On-site; USD 168,000 - 246,000; Full time

Benefits offered by this job

401(k) program

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly in Kenosha, Wisconsin, is seeking a Sr. Director of Parenteral Operations to lead cross-functional teams and guide the site’s manufacturing excellence. You will ensure safety, quality, and compliance across parenteral production while driving strategic plans and performance objectives.

You will mentor the Flow Lead Team, collaborate with Regulatory Agencies, and push continuous improvement to meet OSSCE, CAPA, and Lean standards, contributing to Lilly’s mission to make medicine safely.

Qualifications

• Bachelor's Degree in Engineering, a Life Science, or Business/Operations.
• At least 10 years of experience at a pharmaceutical manufacturing site.
• At least 5 years previous management or leadership experience including cross-functional work.
• Strong leadership, interpersonal and communication skills.
• Supervision of cross-functional teams within a Parenteral production environment.
• Solid understanding of FDA/EMEA/OSHA/EPA regulations.

Responsibilities

• Lead the Parenteral Flow Team and ensure adherence to MSOE standards.
• Develop and implement site strategic and business plans.
• Provide leadership for safety, quality, and operational excellence.
• Mentor direct reports and Flow Lead Team; coach others as needed.
• Maintain state of control for resources and processes used in medicine production.
• Coordinate with Regulatory Agencies during site inspections.
• Drive continuous improvement and reduce process variability.
• Partner with Operational Excellence to deliver MSOE training and day-to-day management.

Skills

Leadership

Cross-functional leadership

Regulatory knowledge

Quality mindset

People management

Communication skills

Education

Bachelor's degree in Engineering/Life Science/Business/Operations

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Sr. Director, Parenteral Operations

The Parenteral Operations Sr. Director is responsible for providing leadership to the cross-functional Process Teams and Flow Teams supporting the parenteral production areas. Utilizing the various teams and functions as described in the Manufacturing Standards for Operational Excellence (MSOEs) to ensure that all people, processes, facilities, and equipment are capable and compliant with the requirements of GMPs, OSHA, and any process and practice designated by the company site or plant as necessary in executing or supporting the making of medicine for our patients.

The Parenteral Operations Sr. Director will be reporting to the Site Head and is a member of the Kenosha Site Lead Team.

Key Objectives/Deliverables

Active member of the Kenosha Site Lead Team ensuring safety, quality, and operational excellence.

Participate in the development and implementation of site strategic and business plans.

Lead the Parenteral Flow Team, in accordance with the Manufacturing Standards for Operational Excellence.

Provide leadership and development to direct reports and members of the Flow Lead Team and be a resource to mentor and coach others as circumstances require.

Meet performance objectives established for the area of responsibility.

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

Make medicine safely.

Make medicine within all quality and compliance guidelines that pharma operations are subject to.

Ensure that the area is capable in respect to key corporate best practices including, but not limited to OSSCE, CAPA, and Lean.

Support site commercialization and new molecule pipeline plan.

Understand and participate in the design of the manufacturing control strategy for formulation, filling, visual inspection

Understand process variability.

Achieve and maintain a state of control for resources and processes used in the making of medicine.

Ensure that occasions when resources or processes are not capable, compliant, or in control are identified, investigated, and corrected.

Where possible and consistent with business needs and objectives, take action to reduce variability and continuously improve performance within the area of responsibility.

Partner with the Operational Excellence/Continuous Improvement organization in the delivery of MSOE training / education programs and drive Operational Excellence in day-to-day management of the operation.

Lead and / or facilitate the implementation of projects and initiatives as identified and sanctioned by the site.

Work with external parties such as Regulatory Agencies during site inspections, other Lilly Parenteral Network Sites, etc.

Utilizing OSSCE, meet patents and other customer supply demands.

Make the workplace more productive by taking advantage of diversity, inclusion, and engagement.

Requirements (Education, Experience, Training)

Bachelor's Degree in Engineering, a Life Science, or Business/Operations

At least 10 years of experience at a pharmaceutical manufacturing site

At least 5 years previous management or leadership experience including leading or working effectively with a cross-functional group.

Previous demonstration of strong leadership skills.

Strong interpersonal and communication skills.

Previous experience in supervision of cross-functional team within a Parenteral production environment.

Solid understanding of quality and corporate policies.

Solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA, EMEA, OSHA, and EPA.

Demonstrated solid judgment and initiative.

Enthusiastic, positive attitude, flexible, and with a growth mindset

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Other Information

Required ability to support personnel working in the aseptic block.

Required ability to wear safety equipment (safety glasses, safety shoes, protective gloves, respirator, etc.).

Some allergens are present in the parenteral 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$168,000 - $246,400

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).

• 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
• 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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