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.
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.
*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.
