Front Line Manufacturing Manager (Downstream) - Night Shift

Amgen•Holly Springs, NC

About The Position

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. T he Amgen FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only feature s the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrate s sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager Manufacturing ( Downstrea m) - Night Shift Live What you will do Let’s do this. Let’s change the world. In t hese vital and dynamic role s you wil l be an on-shift front line manager in manufacturing . The working schedule is based on a day or night shift (12-hour ) rotation. The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. As a m anufacturing leader you will oversee team s 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 biotech nology production operation . In addition, you will support the development of your staff through coaching, hiring, and mentorship . F ont - line M anager 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 a nd 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
U nderstanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Previous k nowledge 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 , a nalytical problem solving , and p roject m anagement 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
Engag e staff and build relationships of trust and respect while driving team performance and continuous improvement
Recruit , train, evaluat e , 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 operation s
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 for a career that defies imagination

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