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Associate Director Manufacturing

Branchburg Township, New Jersey

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Req ID R-9599 Title Associate Director Manufacturing City Branchburg State / Province New Jersey Country United States

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 35,000 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.

Company Overview:

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 39,000 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. #WeAreLilly

Summary:

This position is responsible for the supervision of an area (bioservices, cell culture, or purification) within

manufacturing operations for the commercial and clinical production of monoclonal antibody products. This

position will report to the associate vice president 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.

Primary Responsibilities:

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. Responsible for providing oversight and consistency to the manufacturing teams while continuously reducing variability through the monitoring of all Quality, HSE, and Operational events.

3. 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.

4. Responsible for cGMP compliance, ensuring that all production equipment is properly validated and procedures are maintained within validated state.

5. Ensure cGMP readiness of manufacturing areas for regulatory audits and inspections.  Lead the audits and inspections through the manufacturing area. Author and revise standard operating procedures and batch records.  Review technical reports.  Conduct deviation investigations and write process deviation reports.

6. Develop material/staffing forecasts and detailed production schedules to meet commercial and clinical demand.  

7. Lead continuous improvement projects through capacity optimization and cost reduction programs.

8. Measure and appraise supervisor/operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.

9. Serve as area expert in cross functional meetings.  Champion company policies to area staff. 

10. Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation.

11. Communicate safety and maintenance problems, status of operations, and employee related issues in a timely manner to management.

Required Knowledge, Skills & Education:

1. BA/BS in biology, chemistry, or related discipline, or equivalent work experience.  An MBA a plus.

2. Minimum of 8 years experience in relevant area with a minimum of 5 years of supervisory experience in a cGMP production environment.

3. 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.

4. Must be able to mentor/coach staff as well as lead staff with a high level of honesty and integrity.

5. 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.

6. Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures, and non-conformance event investigations.

7. Must exhibit a team first attitude.

8. Must possess excellent communication, interpersonal, and written skills. 

9. Must meet the physical requirements of the job; must have the ability to: · Lift a minimum of 25 lbs. · Bend, reach, stretch, and climb ladders. · Stand for long periods. · Wear appropriate clean room attire

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-9599.

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.

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