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

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 106,000 - 144,000; Full time

Job summary

Amgen Inc. is seeking a Front Line Manufacturing Manager (Downstream) for the Night Shift in Holly Springs, NC. You will lead manufacturing associates on a 12-hour 2-2-3 schedule, driving safety, compliance, and continuous improvement in a state-of-the-art FleX Batch facility.

The role focuses on downstream purification operations within a 24/7 biotech production environment. Ideal candidates have strong leadership, problem-solving, and project management skills, plus knowledge of cGMP and

Qualifications

• Doctorate or Master’s degree with manufacturing/operations experience
• Bachelor’s degree with 5 years of manufacturing/operations experience OR
• Associate’s degree with 10 years of manufacturing/operations experience OR
• High school diploma and 12 years of manufacturing/operations experience
• Previous managerial experience directly managing people and/or leading teams

Responsibilities

• Lead frontline manufacturing teams on a 12-hour night shift rotation
• Ensure safe, compliant, and efficient GMP drug substance production
• Coach staff and drive Lean and continuous improvement on the floor
• Partner with QA, Regulatory, and other functions to resolve issues and implement CAPAs
• Develop staff through coaching, hiring, and mentorship

Skills

Leadership

Communication

Problem solving

Project management

Coaching / mentoring

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree

Doctorate degree

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic quality systems

Job description

## Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night ShiftApplyremote type: On Sitelocations: US - North Carolina - Holly Springstime type: Full timeposted on: Posted Todayjob requisition id: R-250521## **Career Category**Manufacturing## ## **Job 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. 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) - Night Shift****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. 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 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.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 followedStaff 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 maintainedProcess/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/tasksAdministrative: * 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 now** **for a career that defies imagination**Objects in your future are closer than they appear. Join us.**careers.amgen.com****#AmgenNorthCarolina**.**Salary Range**106,148.00USD -143,612.00 USD