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About the Role

Direct and oversee the production process operations, ensuring safety and compliance with GMP and SOPs. Improve operational efficiency by analyzing and correcting production problems and coordinating with other departments for scheduling and batch record completion.

Responsibilities

• Provide supervision and direction to staff, coordinating workflow, distributing work, and resolving problems.
• Monitor subordinates' attendance, review leave requests, authorize overtime, and approve timecards.
• Manage employee performance through clear definition of responsibilities, feedback, and corrective action.
• Evaluate and appraise employee performance with proper documentation.
• Investigate and address employee complaints, following up with management and HR as required.
• Ensure staff maintain up-to-date technical knowledge and developments impacting their roles.
• Create a learning environment by coaching employees and providing feedback.
• Assist in interviewing and hiring subordinate staff.
• Understand and apply HR policies and practices.
• Conduct ongoing assessment and training needs identification, maintaining training/skill matrices.
• Lead daily production meetings, review performance, and coordinate with other groups for resources.
• Execute the production schedule, anticipating and mitigating operational issues through planning and communication.
• Communicate corporate, department, and shift information effectively.
• Identify weekly labor requirements and develop schedules with management.
• Cover openings due to unexpected absences and break schedules.
• Coordinate activities with other shifts based on production requirements and priorities.
• Develop and maintain departmental cross-functional training matrices.
• Minimize overtime needed to accomplish the production schedule.
• Participate in Safety/GMP Audit Programs.
• Halt processes and notify QA and Management of any concerns for product safety or quality.
• Participate in investigations and prepare PR/Audit documentation.
• Ensure stakeholders are trained on processes and changes.
• Identify and implement improvements in GMP, compliance, waste reduction, and process streamlining.
• Evaluate SOP effectiveness, identify enhancement changes, and ensure change control documentation is implemented.
• Review, edit, and approve Operations documents.
• Monitor production area conditions, ensuring organization, hazard-free, and clean work areas.
• Verify employee adherence to GMPs, safety regulations, and SOPs, addressing violations.
• Hold regular safety meetings.
• Provide direct leadership and oversight of assigned staff, including performance management, evaluations, coaching, mentoring, and goal setting.
• Conduct regular managerial touchpoints with supervisors and team members.
• Partner with Human Resources for workforce planning, staffing, interviewing, and selection.
• Participate in succession planning and organizational development initiatives.
• Support onboarding, training, and ongoing development.
• Demonstrate flexibility and responsiveness to evolving business needs and HR initiatives.
• Foster a culture of accountability, inclusion, engagement, and continuous improvement.

Requirements

• B.S. degree strongly preferred with 2 years related experience preferably in a pharmaceutical or regulated environment; or Associate’s degree with 5 years related experience preferably in a pharmaceutical or regulated environment.
• Two (2) years of supervisory experience preferred.
• Ability to lead and maintain adequate level of performance of individuals engaged in job tasks that are highly structured, routine, and repetitive.
• Ability to resolve problems and issues to ensure efficient flow of manufacturing operations and work completion.
• Basic math skills and ability to understand the metric system required.
• Must be able to lift 50 lbs.
• Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead.
• May drive or operate lifts.
• Works with chemicals, tools, and equipment.
• Pre-employment physical and drug testing required.
• Must wear safety glasses, safety shoes, gloves, and other protective items as required.
• Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.).
• No contact lenses, jewelry (rings, watches, etc.) or make-up are allowed.
• Must be available for flexible schedule and/or overtime. Days and hours of work have subject to change due to production schedules.

Skills

• GMP
• SOPs
• Production Process Management
• Staff Supervision
• Workflow Coordination
• Performance Management
• Employee Coaching
• Interviewing
• Hiring
• HR Policies
• Training Needs Assessment
• Production Scheduling
• Problem Resolution
• Communication
• Cross-functional Training
• Overtime Management
• Safety Compliance
• Quality Assurance
• Process Improvement
• Waste Reduction
• Process Streamlining
• 5S
• Change Control
• Document Review
• Hazard Identification
• Risk Assessment
• Basic Math Skills
• Metric System Understanding
• Chemical Handling
• Tool Operation
• Equipment Operation
• Controlled Substance Handling
• Hazardous Chemical Handling
• cGMP Compliance

Location

• Rochester, NY

Work Type

• Full-time
• Onsite

Experience Level

• 2 years related experience
• 5 years related experience
• 2 years supervisory experience

Education Level

• B.S. degree
• Associate's degree

Salary/Compensations

• 0.00 - 0.00 USD

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses
• Merit increase eligibility

About the Company

• French pharmaceutical industrial group striving to make healthcare solutions accessible.
• World leader in sterile single dose with 10 sites on 4 continents and over 2400 employees.
• Unither Manufacturing LLC. in Rochester (NY) specializes in Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, with over 360 employees.
• Dynamic company driven by a spirit of victory, pursuing strong growth while maintaining close relationships with customers and employees.
• Culture based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
• Committed to granting employees a high degree of autonomy and encouraging initiatives.
• Provides working conditions and atmosphere conducive to development and potential expression.
• Site values the meaning of work and entrusts employees with a high level of responsibility.

Equal Opportunity

• Unither is an Equal Opportunity Employer.
• Committed to providing reasonable accommodations for qualified individuals with disabilities.
• Ensuring equal employment opportunity for all applicants.