Manager, Operations

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.

Qualifications

• 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.
• Able 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 the 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.