Senior Manager - Parenteral Filling Operations
Location: Durham, North Carolina, United States of America
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job ID: R-78827
Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we work to discover and deliver life-changing medicines. Our mission is to improve the understanding and management of disease while giving back to communities through philanthropy and volunteerism.
Compensation:
Actual compensation depends on a candidate’s education, experience, skills, and geographic location.
Anticipated salary: $96,000 - $140,800
Position Overview:
The Senior Manager for Filling Operations in the Parenteral Building is responsible for staffing, training, and leading filling operations. This role requires leading by example, providing coaching, and driving cross-functional excellence in safety, quality, operational execution, sterility assurance, and continuous improvement. The Senior Manager oversees 4 to 8 supervisors managing four 12-hour shift rotations. The team is responsible for commercial operations and qualification activities related to material preparation and movement.
Key Deliverables:
Support site leadership in building a diverse and capable site organization.
Lead a workforce of 40–70 individuals across shifts with multiple supervisors reporting directly.
Ensure operational consistency through Gemba walks and Practice vs. Procedure evaluations.
Develop objectives to achieve Business Plan Goals in production, safety, quality, and financial performance.
Maintain performance metrics and implement necessary changes to improve outcomes.
Drive initiatives such as Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
Lead area deviation and corrective action discussions with Engineering, Maintenance, TS/MS, Quality, and HSE teams.
Act as a primary contact for Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety.
Present operations investigations and procedures to Regulatory Agencies and serve as a Subject Matter Expert (SME).
Lead the Operations Process Team, ensuring continuous improvement and operational excellence.
Represent Operations Process Team on the Plant Flow Team.
Requirements:
Bachelor's degree in science, engineering, or a pharmaceutical-related field.
Prior experience with isolator technology.
Minimum 3 years in a manufacturing environment managing frontline leadership.
At least 1 year in a parenteral manufacturing environment with Grade A classified spaces.
Experience with regulatory audits and managing area tours with auditors.
Prior experience with root cause analysis, technical writing, and knowledge of lean manufacturing principles.
Preferred Skills/Experience:
Facility/area start-up experience.
Knowledge of Manufacturing Execution Systems and electronic batch release.
Solid understanding of FDA/EMEA regulatory requirements.
Ability to wear safety equipment (e.g., safety glasses, gloves, etc.).
Excellent interpersonal, written, and oral communication skills.
Strong technical aptitude with mentoring abilities.
Equal Opportunity Employer:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any legally protected status.
Employee Benefits:
Company bonus (based on performance).
401(k) and pension plans.
Medical, dental, vision, and prescription drug benefits.
Life insurance and disability benefits.
Vacation and leave of absence benefits.
Well-being programs such as EAP and fitness benefits.
#WeAreLilly
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