Operations Manager of Oligo Production

Full-time - Manager

Louisville, KY

10,001+ employees

About the position

The Operations Manager of Oligo Production is responsible for the oligonucleotide manufacturing operation and implementation of activities to meet production goals, quality, and cost objectives. Perform activities in concordance with FDA-QMS/QSR and ISO-9001 standards; ensure compliance with environmental, health and safety regulations. Select, develop, and evaluates personnel to ensure the efficient operation of the function. Plan and administer procedures and budget, serve as a manufacturing representative and technical expert. This position is full time onsite in Louisville KY, Monday to Friday.

Responsibilities

• Provide overall direction, coordination, coaching and evaluation of multiple direct reports for a Manufacturing Organization
• Drive major projects and programs for Organizational Unit or Function to completion within schedule and budget
• Conduct briefings and participate in technical meetings for senior management and external representatives concerning specific operations
• Collaborate with support groups to reach mutually agreed-upon deadlines
• Manage process changes to support overall cGMP compliance
• Review and continuously improve the state of operations from fiscal overview to area walk-throughs
• Monitor and continually evaluate opportunities to improve key performance indicators (KPIs) and work with management and cross-functional teams to drive CI projects
• Identify and report potential operational risks and issues to senior management and lateral operational managers
• Monitor Personnel Cost, Consumable Cost, Overtime hours
• Represent technical operations for site and interdepartmental meetings
• Leads the teams and manages individual contributors (Supervisor, Team Leads, Production Chemists, Lab Technicians, contractors)
• Maintains skill set matrix for Operations Team
• Works on problems of diverse scope including multiple projects and/or objectives
• Develops and administers schedules and monitors progress (KPI) against objectives. Safety/Quality/TAT/5S
• Prepares KPI reports and communicate regularly with other managers, upper management, and other designated contacts within the organization
• Coaches subordinate(s) on job performance and development
• Leads validation activities of new projects and equipment
• Reviews weekly KPI reports
• Coordinates weekly safety training and recruitment process within department
• Ensures and adheres to GMP compliance and maintain a clean/ traceable work environment.

Requirements

• A minimum of a Bachelor's degree in engineering, chemistry, biochemistry, or similar field. Ph.D. is highly preferred.
• A minimum of 3 years of managerial experience in manufacturing or oligonucleotide field or similar field.
• Proficiency of organic synthesis and purification techniques.
• Effective organization and planning skills.
• Working knowledge of GMP, ISO, and QSR regulations.
• Experience in documenting and analyzing experimental data.
• Strong computer, scientific, and organization skills.
• Excellent communication (oral and written), and attention to detail.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays