Associate Director - Purification Manufacturing

Job Opportunity at Lilly

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.

Organization Overview

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of making medicine with safety first and quality always; following our common purpose under TEAM Lilly and our manufacturing standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Responsibilities

This position is responsible for the supervision of the Purification Area within manufacturing operations for the commercial and clinical production of monoclonal antibody products. This position will report to the senior director of the area and will interact with engineering, maintenance, validation, quality assurance, quality control, manufacturing technology, and logistics departments. As needed, further interaction will be required with material vendors and commercial partners. Knowledge of all areas of operations and support systems, along with spreadsheets and databases is essential. The associate director is responsible for leading their respective process team per Manufacturing Standard for Operational Excellence (MSOE) 601 & 602 and is a member of the Flow Team and other process / functional teams, as appropriate.

Additional Skills / Preferences

1. Responsible for leading the Process Team per Manufacturing Standard for Operational Excellence (MSOE) 601 & 602, specifically focusing on safety, quality, and manufacturing performance through the use of appropriate performance metrics and targets. 2. Will have reporting responsibilities for the frontline staff either directly or indirectly through frontline supervision. 3. Responsible to know the Operational Control Strategy and for providing oversight and consistency to the manufacturing teams while continuously reducing variability through the monitoring of all Quality, HSE, and Operational events. 4. Responsible for focusing on the elimination of critical events and the subsequent reduction of recurrent situations using, but not limited to, trend analysis and process mapping. 5. Responsible for cGMP compliance, ensuring that all production equipment is properly validated, and procedures are maintained within validated state. 6. Ensure cGMP readiness of manufacturing areas for regulatory audits and inspections. Lead the audits and inspections through the manufacturing area. 7. Author and revise standard operating procedures and batch records. Review technical reports. Conduct deviation investigations and write process deviation reports. 8. Develop material / staffing forecasts and detailed production schedules to meet commercial and clinical demand. 9. Lead continuous improvement projects through capacity optimization and cost reduction programs. 10. Measure and appraise supervisor / operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations. 11. Provide input on the Performance Management Plan for Process Team Members as well feedback on performance. Functional Leader alignment on Process Team members is critical for a successful team performance, Process Team Leader should facilitate that alignment. 12. Serve as area expert in cross functional meetings. Champion company policies to area staff. 13. Contribute and adhere to safety, environmental, quality, and EEO / AA standards of the Corporation. 14. Communicate safety and maintenance problems, status of operations, and employee related issues in a timely manner to management. 15. Should escalate issues to appropriate management level when necessary, following the appropriate notification to management process.

Manage Relationships with Key Stakeholders and Customers

1. Drive cross functional alignment and integration at Process Team. 2. Be the liaison between the Process Team and other teams and leaders of the site.

Staff Development and Management

1. Measure and appraise front line supervision performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations. 2. Ensure staff are trained in manufacturing process / operations following standard operating procedures and cGMP guidelines. 3. Ensure development plans for front line staff and supervisors are in place and active. 4. Appropriately managing medical cases following Employee Health Services recommendations 5. Mentor / coach staff as well as lead staff with a high level of honesty and integrity

Basic Requirements

1. Minimum of 7 years' experience in relevant area. Previous supervisory experience is preferable. 2. Must be able to make critical decisions 7 days / week. Must be able to effectively (clearly and accurately) communicate decisions to staff and upper management. 3. Must be able to mentor / coach staff as well as lead staff with a high level of honesty and integrity. 4. Must have a thorough theoretical understanding and technical proficiency of operations within an area. Must be able to apply technical and operational experience to solve complex problems. 5. Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures, and non-conformance event investigations. 6. Must exhibit a team first attitude. 7. Must possess excellent communication, interpersonal, and written skills. 8. Must meet the physical requirements of the job; must have the ability to : a. Bend, reach, stretch, and climb ladders. b. Stand for long periods. c. Wear appropriate clean room attire.

Education Requirements

1. BA / BS in biology, chemistry, or related discipline, or equivalent work experience.

Additional Information

1. Travel not required. 2. Lifting not required. 3. Required to be on call. 4. Shift work may apply. 5. 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. 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 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), enAble (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 $135,000 - $198,000. 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.