Director of Operations

This position reports directly to the VP of Pharmaceutical Manufacturing Operations.  The Director of Operations is responsible for the overall production functions including Formulation, Filling, Sanitization and VILP (Visual Inspection, Labeling and Packaging) of the Denver facility to produce cGMP compliant drug products, which meet all quality standards, customer expectations, and are produced in a safe and cost-effective manner.

Why Join Leiters Health? 

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! 

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. 

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For: 

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! 

Essential Functions:

• Responsible for the timely and in-full execution of production plans.
• Ensures compliance to cGMP standards, internal procedures and product quality standards. 
• Works cooperatively with all functional areas of the business to facilitate innovation while ensuring the delivery of products and services of the highest quality and compliance.
• Liaison with all relevant regulatory bodies including the FDA and State Boards of Pharmacy. 
• Works cross functionally to facilitate product registrations, field actions/recall management, product life cycle management and asset management in line with business objectives.
• Delivers service levels in line with customer and company expectations. 
• Accurate and focused management of budgeted expenses. 
• Fosters a continuous process improvement environment.
• Other duties as assigned.

Supervisory Responsibilities: 

• Leads 3-5 direct reports across the Manufacturing (Formulation, Filling, Sanitization) & VILP groups. 
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration. 
• Conduct regular 1:1’s to address performance, feedback and relationship building.
• Identify training and development needs within the team and facilitate as able. 

Experience and Necessary Skills:

• Bachelor’s degree in engineering, science or related discipline required. Master’s degree preferred. 
• 7 years in related Manufacturing Operations required.  5 years in a significant managerial role preferred. 

• Demonstrated knowledge of cGMP guidelines/standards is required. 

• Working knowledge of Lean Manufacturing/6 Sigma principles.
• Comprehends standard operating procedures, forms, training, and quality control activities.
• High integrity, good judgment, in a matrixed environment.
• Excellent organizational skills. 

• Team player and proven flexibility; high degree of motivation. 


• Strong hands-on, “roll up your sleeves” attitude, with emphasis on achieving results.
• Ability to think strategically and execute on strategy.
• Strong experience in project and budget management.
• Excellent people management, analytical and problem-solving skills.
• Demonstrated written and oral communications skills including strong presentation skills.
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. 

Physical Requirements:

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically. 
• Ability to maintain a gowning qualification, if applicable.

Benefits: 

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance 
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program 

Timeline: We will be accepting applications on an ongoing basis until position is filled.  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. 

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.