Operations Manager (3rd Shift)
Leiters Inc
Job Description
Job Description
The Operations Manager on third shift is responsible for leading day-to-day pharmaceutical manufacturing operations across formulation, filling, inspection, labeling & packaging, and cleanroom services activities. This role ensures safe, compliant, and efficient production by driving adherence to cGMP, SOP, and safety requirements while providing strong leadership, employee development, and cross-functional collaboration.
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:
- Manage and oversee manufacturing operations to ensure safe, compliant, and efficient execution of production activities in accordance with SOPs, cGMP requirements, and company standards.
- Ensure manufacturing documentation, batch records, logs, and procedures are maintained accurately, completely, and in an audit-ready state.
- Drive operational excellence by proactively identifying, troubleshooting, and resolving production issues while ensuring the availability of required equipment, materials, and resources.
- Lead deviation investigations, root cause analyses, and the implementation of effective corrective and preventive actions (CAPAs) to minimize recurrence and maintain product quality.
- Partner cross-functionally to support manufacturing objectives and resolve operational challenges.
- Oversee production planning and scheduling activities, including coordination of process validations, equipment qualifications, maintenance activities, and manufacturing priorities.
- Monitor and analyze key performance indicators, production metrics, and operational reports to drive informed decision-making and continuous improvement.
- Identify, recommend, and implement process, equipment, and workflow improvements that enhance safety, quality, compliance, productivity, and cost efficiency.
- Evaluate and recommend strategic investments to improve manufacturing capabilities, capacity, reliability, and long-term business performance.
- Other duties as assigned.
Supervisory Responsibilities:
- Directly hire and lead a team of supervisors, leads and technicians.
- 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 Competencies:
- Bachelor’s degree in Life Sciences, Pharmacy or Engineering or equivalent experience.
- 5+ years of leadership experience in a cGMP pharmaceutical manufacturing environment.
- Advanced problem solving such as Six Sigma and Lean training, Black belt of Green belt preferred.
- Excellent at bringing others together and reconciling differences effectively.
- Able to work in a fast-paced environment and adaptable to change.
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is required
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Competencies:
- Drive for Results - Consistently achieves goals and delivers high-quality results through accountability, urgency, and execution.
- Process Management - Effectively manages and improves processes to ensure safe, compliant, and efficient operations.
- Problem Solving - Identifies root causes, analyzes issues, and implements effective solutions to operational challenges.
- Managing and Measuring Work - Establishes clear expectations, monitors performance, and holds teams accountable for achieving objectives.
- Building Effective Teams - Develops a collaborative, high-performing team culture that promotes engagement, accountability, and continuous improvement.
Physical Requirements:
- Ability to stand or sit for extended periods of time.
- Ability to stoop, crawl, bend, walk for extended periods of time, if applicable.
- Ability to lift, push and pull up to 25 pounds periodically.
- Ability to maintain a gowning qualification.
Schedule: Monday - Friday 11:30pm - 8am
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.
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