Front Line Manufacturing Manager (Downstream) - Night Shift

Amgen • Holly Springs, NC

4d

About The Position

In these vital and dynamic roles you will be an on-shift front line manager in manufacturing. The working schedule is based on a day or night shift (12-hour) rotation. As a manufacturing leader you will oversee teams of manufacturing associates with differing levels of experience who will be responsible for the manufacture of GMP drug substances. Through structured on the floor presence, you will champion a safe and compliant production environment. As an active participant and role model in a Lean and continuous improvement culture, the manager will imbed these principles onto the manufacturing floor. Through your leadership, you will oversee teams in technical, on the floor operations in a biotechnology production operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship. Font-line Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering short- and long-term Amgen Operational goals.

Requirements

• Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

• Bachelor’s degree in Life Sciences or Engineering
• Demonstrated strong leadership skills and technical understanding of biotechnology production operations
• Experience in biotechnology or pharmaceutical plant start up
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Previous knowledge and experience within a cGMP environment
• 5+ years process experience in a cGMP manufacturing facility
• 3+ years of experience in a production Area Lead, Specialist or Manager role
• Strong leadership and teambuilding skills (coaching, mentoring, counseling)
• Experience with performance management including performance reviews
• Conflict Resolution, analytical problem solving, and project management skills
• Thorough understanding of regulatory requirements
• Excellent verbal and written communication (technical) skills
• Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

Responsibilities

• Ensure safe working environment
• Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
• Evaluate current operating procedures and recommend changes to management to optimize production.
• Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes
• Interact with regulatory agencies as needed
• Assure proper gowning and aseptic techniques are followed
• Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
• Recruit, train, evaluate, coach and develop staff
• Mentor and coach staff members to live by the Amgen Values
• Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
• Ensure adherence to production schedule and maintenance activities
• Interacts with management in optimizing organizational structure and responsibilities
• Ensure plant safety through auditing, evaluations, and cross functional walks
• Ensure gowning and aseptic techniques training programs are maintained
• Demonstrate technical mastery of manufacturing processes
• Collaborate with cross-functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities
• Develop, implement and assess CAPAs and solutions to complex problems
• Responsible for elevating and resolving problems during daily operations
• Oversees set up, execution, and completion of critical manufacturing processes/tasks
• Interacts with management in planning, developing and maintaining budget
• Assist in developing and maintaining department goals

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED