Senior Director - Parenteral Operations

Eli Lilly and Company; Kenosha (WI); Presencial; USD 168 000 - 246 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus eligible

401(k) + pension

Vacation benefits

Resumo da oferta

Lilly in Kenosha, WI is seeking a Sr. Director, Parenteral Operations to provide cross-functional leadership for parenteral production.

You will oversee the Parenteral Flow Team and ensure process capability, quality, and regulatory compliance across the site, reporting to the Site Head as part of the Kenosha Site Lead Team. You will drive safety, operational excellence, and continuous improvement, mentoring direct reports and collaborating with external regulators as needed to meet production

Qualificações

• Bachelor's degree in engineering, life science, or business/operations.
• 10+ years of experience at a pharmaceutical manufacturing site.
• 5+ years of management or leadership experience including cross-functional work.
• Strong interpersonal and communication skills.
• Solid understanding of regulatory agencies such as FDA, EMEA, OSHA, EPA.

Responsabilidades

• Lead the Parenteral Flow Team and cross-functional process teams.
• Ensure safety, quality and operational excellence within the Kenosha Site.
• Develop and implement site strategic and business plans.
• Mentor and develop direct reports and team members.
• Achieve performance objectives and maintain a safe work environment.
• Support regulatory inspections and site improvements in line with MSOEs.

Conhecimentos

Leadership experience

Cross-functional collaboration

Interpersonal communication

Regulatory / GMP knowledge

Formação académica

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

Descrição da oferta de emprego

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).

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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