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About the Role

Reporting to the Production Manager, this role oversees production process operations, ensuring safety and compliance with GMP and SOPs. The position focuses on improving operational efficiency by analyzing and correcting production problems and coordinating with other departments for scheduling efficiency and batch record completion.

Responsibilities

Provides supervision and direction to staff, coordinating workflow, distributing work, disseminating information, assigning staff, providing technical assistance, answering questions, and resolving problems.
Ensures work is scheduled effectively and checkpoints and controls are set for monitoring progress.
Monitors subordinates’ attendance, reviews and approves vacation and leave requests, authorizes overtime, and verifies and approves timecards.
Manages employee performance by defining job responsibilities and standards, providing feedback, and addressing performance problems through corrective action.
Evaluates and appraises employees’ performance with proper documentation.
Investigates and addresses employee complaints, following up with Manager and HR as required.
Ensures self and staff maintain up-to-date technical knowledge.
Creates a learning environment by coaching employees, orchestrating learning opportunities, and providing feedback.
Assists in interviewing and hiring subordinate staff.
Understands and applies HR policies and practices in employee management.
Conducts ongoing assessment and training needs identification, maintaining the training/skill matrix for the assigned shift.
Creates learning opportunities for all staff as part of daily operations.
Follows up on and investigates process deviations, identifying root causes and providing effective CAPAs.
Leads daily production meetings, reviews performance, and coordinates with other groups for information and resources.
Executes the production schedule, anticipating and mitigating operational issues through planning and communication.
Actively communicates corporate, department, and shift-to-shift information.
Identifies weekly labor requirements and develops schedules in conjunction with the Manager.
Participates in covering openings due to unexpected absences and break schedules.
Coordinates activities with other shifts based on production requirements, priorities, and material availability.
Develops and maintains the departmental cross-functional training matrix to support production and fill vacancies.
Actively manages overtime to minimize hours required to meet the schedule.
Participates in Safety/GMP Audit Programs.
Halts process and notifies QA and Manager of any concerns about Product Safety or quality.
Participates in investigations and prepares PR/Audit documentation.
Ensures stakeholders are trained on the process and any process changes.
Identifies and implements opportunities for improvement in GMP, compliance, waste reduction, and process streamlining.
Evaluates SOP effectiveness, identifies process enhancement changes, and ensures change control documentation is implemented.
Reviews, edits, and approves Operations documents.
Monitors Production area conditions to ensure organization, hazard-free status, and cleanliness.
Verifies that employees follow company GMPs, safety regulations, and workplace SOPs, addressing violations and notifying Manager.
Holds regular safety meetings.

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; and 2 years previous supervisory experience preferred.
Previous food/drug/chemical industry experience.
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 pounds to lift and maneuver bulk containers of ingredients.
Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead and be able to stand for extended periods of time while performing duties.
Considerable mental/visual concentration, coordinating manual dexterity.
Must be able to operate power equipment; routinely drives/operates lifts.
Must be able to work safely with materials and equipment; works with chemicals, tools, and equipment.
May work in an environment with variable but moderately high noise levels (hearing protection recommended).
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.).
Must be available for flexible schedule and/or overtime.
Days and hours of work are subject to change due to production schedules.
Works with chemicals, tools and other equipment.

Skills

Supervision
Production process oversight
GMP compliance
SOP adherence
Problem-solving
Process improvement
Team leadership
Performance management
Training and development
Root cause analysis
CAPA implementation
Production scheduling
Resource management
Cross-functional training
Overtime management
Safety compliance
Audit participation
Documentation review
Basic math skills
Metric system understanding

Location

Rochester, NY

Work Type

Full-time
Onsite

Experience Level

2 years related experience
5 years related experience
2 years previous supervisory experience preferred

Education Level

B.S. degree preferred
Associate’s degree

Salary/Compensations

82,000.00 - 92,000.00 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

A French pharmaceutical industrial group striving to make healthcare solutions accessible.
A 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.
A 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 employee development and potential expression.
A site that 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.