Front Line Manufacturing Manager (Downstream) - Night shift

Amgen; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Front Line Manufacturing Manager to lead a dynamic team in a state-of-the-art facility. This role involves overseeing GMP drug substance production while fostering a culture of safety and continuous improvement. The ideal candidate will have a strong background in manufacturing operations and leadership, with a passion for driving performance and innovation. Join a mission-driven organization dedicated to transforming the lives of patients through cutting-edge biotechnology. This opportunity offers a collaborative environment, competitive benefits, and the chance to make a meaningful impact in healthcare.

Benefits

Competitive Benefits

Professional Growth Opportunities

Collaborative Culture

Qualifications

• Management experience in a regulated manufacturing environment.
• Experience in biotech or pharma startup is preferred.

Responsibilities

• Supervise a team of manufacturing associates in GMP production.
• Ensure compliance with safety and regulatory standards.

Skills

Leadership

Coaching

Conflict Resolution

Project Management

Communication Skills

Education

High School Diploma/GED

Associate's Degree

Bachelor's Degree

Master's Degree

Doctorate Degree

Tools

Microsoft Office

MES

Delta V

Electronic Quality Systems

Job description

Front Line Manufacturing Manager (Downstream) - Night shift

Join us to apply for the Front Line Manufacturing Manager (Downstream) - Night shift role at Amgen.

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Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 feature industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, supporting Amgen's goal to be carbon-neutral by 2027.

What You Will Do
Let’s do this. Let’s change the world. In this vital role, you will be an on-shift front line manager in downstream manufacturing. The initial schedule will be Monday-Friday 10-hour days, with potential work from home. The schedule will transition to a day or night shift (12-hour rotation) upon startup completion.

As a manufacturing leader, you will supervise a team of manufacturing associates responsible for GMP drug substance production. You will champion a safe, compliant environment, and promote a LEAN and continuous improvement culture.

You will lead all aspects of technical, on-the-floor operations and support staff development through coaching, hiring, and mentorship.

All front-line managers will help define area objectives, identify improvements, and lead change efforts to meet Amgen's operational goals.

Responsibilities

Compliance:

• Ensure a safe working environment
• Maintain cGMP and CFR compliance
• Follow Amgen policies and procedures
• Evaluate operating procedures and recommend improvements
• Interact with regulatory agencies as needed
• Ensure proper gowning and aseptic techniques

Staff Supervision:

- Engage staff, build trust, and drive performance
- Handle staff selection, training, evaluation, and development
- Mentor staff to uphold Amgen values
- Develop training programs to ensure compliance
- Maintain adherence to production schedules and maintenance
- Collaborate with management to optimize organizational structure
- Conduct safety audits and evaluations
- Maintain gowning and aseptic technique training

Process/Equipment/Facilities:

- Demonstrate technical proficiency in manufacturing processes
- Collaborate across functions (QA/QC, F&E, PPIC, Mfg, PD, Regulatory)
- Develop and assess CAPAs and solutions
- Resolve operational issues
- Oversee manufacturing processes

Administrative:

- Assist in planning and maintaining budgets
- Help develop department goals

What We Expect Of You
The ideal candidate will have management experience and meet at least one of the following educational/experience criteria:

• High school diploma/GED + 12 years manufacturing/operations experience
• Associate’s degree + 10 years manufacturing/operations experience
• Bachelor’s degree + 5 years manufacturing/operations experience
• Master’s degree + 3 years manufacturing/operations experience
• Doctorate degree

In addition, you must have experience managing people or leading teams/projects/resources, which may run concurrently with your technical experience.

Preferred Qualifications
- Bachelor’s in Life Sciences or Engineering
- Experience in biotech or pharma startup
- Knowledge of downstream purification (Chromatography, TFF, Viral Filtration)
- 5+ years in a regulated manufacturing environment
- 3+ years in a leadership role
- Strong leadership, coaching, and mentoring skills
- Experience with performance management
- Conflict resolution and project management skills
- Regulatory knowledge
- Excellent communication skills
- Proficiency with Microsoft Office, MES, Delta V, and electronic quality systems

What You Can Expect From Us
We support your professional and personal growth, offering competitive benefits and a collaborative culture. Our Total Rewards Plans are competitive and aligned with industry standards.

Join us to develop treatments that improve lives. Your future is closer than you think. Apply now at careers.amgen.com.