Associate Director, Parenteral Operations

Initial Therapeutics, Inc.; Concord (NC); On-site; USD 118,000 - 174,000; Full time

Job summary

An established industry player is seeking an Associate Director for Parenteral Operations in Concord, NC. This pivotal role involves leading a dedicated team in a new state-of-the-art facility, ensuring operational excellence, compliance, and continuous improvement. The ideal candidate will have a strong background in the pharmaceutical industry, with a focus on leadership and regulatory standards. Join a forward-thinking organization that values integrity, excellence, and respect for people, and make a significant impact on the production of life-changing medicines. If you are passionate about improving lives and have the expertise to lead operations, this opportunity is perfect for you.

Qualifications

• 7+ years in the pharmaceutical industry with leadership experience.
• Solid understanding of regulatory agency requirements.

Responsibilities

• Lead operations group in parenteral operations and process development.
• Ensure production goals are met and promote safety and quality.

Skills

Leadership

Interpersonal Communication

Technical Aptitude

Regulatory Knowledge

Continuous Improvement

Education

Bachelor's Degree in STEM or Pharmaceutical Field

Associate Degree

Job description

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Associate Director, Parenteral Operations

Discipline: Manufacturing & Production, Operations

Required Education: Associate Degree

Position Type: Full time

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 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.

Position Description

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 with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People.

Position Overview

Lilly is investing over $1 Billion to build a new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.

The Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require domestic travel with the opportunity for international travel to collaborate and learn from sites that produce our medicines.

Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching in safety, quality, operational excellence, compliance, and continuous improvement.

Key Objectives / Deliverables

Integrity

• Leading by example with a Safety first, Quality Always mindset.
• Lead/conduct area deviation and corrective action discussions with a cross-functional team.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME).

Excellence

• Ensure consistency of operations across shifts.
• Maintain and communicate metrics to measure performance against business objectives.
• Participate in the development and implementation of strategies focused on Continuous Improvement, Root Cause Analysis, and Operational Standards.

Respect for People

• Support Site Leadership to build a diverse and capable site organization.
• Responsible for a workforce of approximately 40 – 70 individuals with multiple shift supervisors reporting directly.
• Provide leadership and develop objectives to deliver Business Plan goals.

Requirements (Education, Experience, Training)

Education, Experience, and Capabilities

• Bachelor's degree in a STEM or pharmaceutical related field.
• At least 7 years working in the pharmaceutical industry.
• Previous management or leadership experience.
• Solid understanding of regulatory agency requirements.
• Excellence in interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.

Time Commitments, Environment, and Work Authorization

• Ability to wear safety equipment.
• Ability to work 8 hours per day Monday through Friday with overtime as required.
• Position will involve frequent business trips domestically with potential international travel.

Preferred attributes but not required

Experience with, completion of, or understanding of:

• 6+ years in manufacturing/operations with 4+ years in a supervisory role.
• cGMP standards and FDA guidelines for production.
• Aseptic filling, single use assemblies, isolator technology.

This job specification is intended to provide a general overview of the job requirements. The job requirements may change over time and may include additional responsibilities not specifically described. As always, consult with your supervisor regarding your actual job responsibilities.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on any legally protected status.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876. More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve.

Company info

Location: 893 S Delaware St, Indianapolis, Indiana, 46285, United States

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800.