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

Benefits offered by this job

Retirement plan

Bonuses

Stock-based incentives

Time-off plans

Remote-friendly

Job summary

Amgen Inc. in the United States is seeking a frontline manufacturing leader for the FleX Batch facility, responsible for overseeing GMP drug substance production on a 12-hour day/night 2-2-3 schedule.

You will coach and mentor staff, champion Lean and continuous improvement, and coordinate with QA/QC, F&E, PPIC, and other functions to meet production goals while ensuring safety and regulatory compliance.

Qualifications

• Doctorate or Master’s with manufacturing/ops experience.
• Bachelor’s with manufacturing/ops experience.
• Associate’s or high school with extensive manufacturing/ops experience and prior leadership.

Responsibilities

• Ensure safe working environment and cGMP compliance.
• Recruit, train, coach and develop staff; drive team performance.
• Collaborate with cross-functional teams to complete production activities; implement CAPAs.
• Plan, develop and monitor department goals and budgets.

Skills

Leadership

Project management

Communication

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

DeltaV

MES

Electronic quality systems

Job description

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.

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 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 training 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.

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

• 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.

Salary and Benefits

The annual base salary range for this opportunity in the U.S. is provided below.

Salary Range 106,148.00USD -143,612.00 USD

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen