Front Line Manufacturing Manager (Downstream) - Night Shift
Front Line Manufacturing Manager (Downstream) - Night Shift
US - North Carolina - Holly Springs Apply NowHOW MIGHT YOU DEFY IMAGINATION?
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. The 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 features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Manager Manufacturing (Downstream)
Live
What you will do
Let’s do this. Let’s change the world. 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.
Responsibilities
Compliance:
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
Staff Supervision:
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
Process/Equipment/Facilities:
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
Administrative:
Interacts with management in planning, developing and maintaining budget
Assist in developing and maintaining department goals
Win
What we expect from you
We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these qualifications.
Basic Qualifications
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
AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
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
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is provided below.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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
Apply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.
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