Senior Director API EM Operations – Large Molecule

Posted 7 Days Ago
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Indianapolis, IN
152K-222K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Director API EM Operations for Large Molecule is responsible for overseeing production operations of contract manufacturers, ensuring they meet quality, safety, and customer needs. This role requires leadership to manage cross-functional teams, develop relationships with CMs, and drive continuous improvement in processes.
Summary Generated by Built In

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.

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

$151,500 - $222,200

Organization Overview:

The Senior Director API EM Operations – Large Molecule is responsible for providing leadership and oversight for the production operations of Large Molecule contract manufacturers (CMs) under the oversight of API External Manufacturing (API EM), integrating all functional requirements to ensure quality, safety, and customer requirements are met through the lifecycle of external partnerships (partner selection, technology transfer, operation, relationship exit).

Technology that is considered Large molecule include:  mAbs, ecoli, conjugated mAbs, gene therapy, cell therapy.

This position will work cross-functionally to build a business plan, meet commitments, and drive for continuous improvement.

Responsibilities:

  • Ensuring staff are qualified and that the required initial and continuing training of all operations personnel is carried out and adapted according to need.
  • Accountable for the execution of MSOE 204 as it applies to each of the CM relationships
  • Relationship development with each CM in order to ensure baseline governance of the contractual obligations and deliver value creation
  • Staffs and leads a cross-functional team to execute the expectations outlined in MSOE 601for the hub lead team under their area of responsibility
  • Establish required Process Teams, complying with the expectations established in MSOE 602 – Process Teams
  • Lead required Flow teams / plant lead team, complying with the expectations established in MSOE 601- Manufacturing Site and Plant Governance.
  • Accountable to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.

Basic Requirements:

  • High-quality skills to include:  Teamwork and interpersonal, technical, leadership, project management, administrative, financial background, organizational, independent, decision making, multi-tasking, ability to influence diverse groups, communication skills, computer skills, and problem solving.
  • Good understanding of OSSCE and its integration within a plant.
  • Relevant foundational experiences in process engineering, quality control, process development or technical services. 
  • Administrative experience as a leader of operations or technical support functions.
  • Bachelor’s degree or equivalent in Chemical Engineering, Mechanical Engineering, Chemistry/Biochemistry or related science

Additional Information:
Up to 15% travel could be required

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

#WeAreLilly

The Company
HQ: Indianapolis, IN
39,451 Employees
On-site Workplace
Year Founded: 1876

What We Do

Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment.

For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

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