Job Description

The Operations Manager is a strategic leader responsible for overseeing the end-to-end execution of clinical and commercial packaging, labeling, manufacturing, and assembly of drug products and finished goods. This includes blistering, bottling, carding, encapsulation, and related operations. This role ensures operational excellence, regulatory compliance, and customer satisfaction, while driving continuous improvement and innovation across the department. The Operations Manager leads a high-performing team, fosters a culture of accountability, and partners cross-functionally to meet project timelines and quality standards.

Essential Duties and Responsibilities

• Lead and oversee all aspects of clinical and commercial packaging operations, ensuring alignment with company SOPs, cGMP regulations, and industry best practices.
• Develop, monitor, and optimize key performance indicators (KPIs) to drive operational efficiency, quality, and customer satisfaction.
• Own the production schedule, balancing resource allocation, capacity planning, and client timelines to ensure on-time delivery.
• Assess and enhance facility layout, workforce planning, and equipment utilization to support scalability and continuous improvement.
• Inspire and develop high-performing teams through coaching, performance management, and leadership development initiatives.
• Strengthen team capabilities by identifying skill gaps, implementing targeted training programs, and supporting cross-training and succession planning.
• Champion continuous improvement, leveraging Lean, Six Sigma, or other methodologies to streamline processes and reduce waste.
• Collaborate cross-functionally with Logistics, Quality, Project Management, and external partners to proactively resolve operational challenges.
• Conduct and document performance evaluations, providing actionable feedback and development plans.
• Lead investigations into deviations, complaints, and non-conformances, applying root cause analysis and implementing corrective/preventive actions.
• Promote a safe and secure work environment, enforcing company policies and safety protocols.
• Participate in audits and client visits, representing the department and driving resolution of findings.
• Other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The minimum requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Previous production manager or senior supervisory experience in a regulated industry required.
• 5+ years of previous experience in clinical and/or commercial packaging or manufacturing, with at least 3 years in a supervisory or managerial capacity.
• Proficient with interpreting and implementing cGMP, FDA, DEA, and OSHA regulations.
• Bachelor’s Degree or equivalent experience.
• Strong leadership to mentor and develop team to achieve company goals.
• Ability to exercise advanced reasoning and sound judgment to forecast outcomes and make decisions that position the department for successful results, even where established processes are limited.
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts. Ability to speak effectively before a group of any combination of the above.
• Working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.
• Must have the ability to work in a cross-functional team environment.
• Strong leadership skills to mentor and develop team to achieve company goals.

Language Skills:

Strong ability to read, write and comprehend the English language, read and interpret legal and technical documents, and write routine correspondence. Ability to communicate effectively with employees at all levels of the company. Strong verbal and written communication and presentation skills; able to convey technical and procedural content clearly to diverse audiences.

Reasoning Ability:

Ability to apply advanced critical thinking to anticipate outcomes and make decisions that drive the department toward successful results. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to handle multiple tasks and make sound decisions. Able to assess training gaps and develop appropriate solutions.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to traverse the facility. This position is required to occasionally perform repetitive actions that entail frequent bending and lifting. Prolonged periods of standing and walking may be frequently required. Must be able to frequently operate a computer and/or other office machinery. Must be able to lift up to 25 lbs at a time. May be required to travel by automobile, plane, train or other form of public transportation on an infrequent basis. May be required to effectively and safely operate material handling equipment on an infrequent basis.

Environmental Conditions

The noise level in the work environment is usually moderate. While performing the duties of the job, this position is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts.

This position is required to be onsite in order to perform essential functions and responsibilities.