Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

Career CategoryManufacturingJob Description
HOW 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. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Manager Manufacturing (Upstream) - Night Shift
What you will do
Let’s do this. Let’s change the world. In this dynamic role you will be the on-shift front line manager in manufacturing. The schedule is night shift (2-2-3, 12-hour rotation), 5:45PM to 6:15AM. The successful candidate will be leading a team of experienced manufacturing associates responsible for the manufacture of GMP (Good Manufacturing Practices) drug substance. The manager will champion a safe and compliant production environment through structured on floor presence. The manager will be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
With minimal direction the manager is responsible for leading on the floor operations and staff in manufacturing. The successful candidate must demonstrate strong leadership skills and technical understanding of biotechnology production operations. This individual will be responsible for supervising, coaching, hiring, and development of floor staff.
The front-line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short- and long-term Amgen Operational goals.
Responsibilities
Compliance:
Ensure safe working environment for all
Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and EHSS (Environmental, Health, Safety and Sustainability) on change controls
Interact with regulatory agencies as needed
Assure proper gowning and aseptic techniques are followed
Staff Supervision:
Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
Responsible for selection, training, evaluation, staff relations and staff development
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
Process/Equipment/Facilities:
Demonstrate technical mastery of manufacturing processes
Collaborate with cross-functional teams (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg, PD (Process Development), Regulatory, etc.) in completing production activities
Develop, implement, and assess CAPAs (Corrective Action Preventive Action) 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
Other functional responsibilities may be assigned
Basic Qualifications
Doctorate degree
OR
Master’s degree and 3 years of Manufacturing and/or operations experience
OR
Bachelor’s degree and 5 years of Manufacturing and/or operations experience
OR
Associate degree and 10 years of Manufacturing and/or operations experience
OR
High school diploma / GED and 12 years of Manufacturing and/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
Experience in biotechnology or pharmaceutical plant start up
Basic understanding of upstream and/or downstream operations
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Knowledge and experience within a cGMP or other highly regulated 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