Front Line Manufacturing Manager (Downstream) - Night shift

Amgen; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to serving patients through innovative biotechnology. As a Front Line Manufacturing Manager, you will lead a dynamic team in a state-of-the-art facility, ensuring compliance and safety while driving continuous improvement. This role offers the chance to make a significant impact in the lives of patients and contribute to groundbreaking advancements in drug manufacturing. With a collaborative culture and a commitment to professional growth, you will thrive in an environment that values your contributions and supports your career development. Embrace the opportunity to transform your career while making a difference in the world.

Benefits

Competitive Benefits

Collaborative Culture

Professional Growth Opportunities

Health Insurance

Retirement Plans

Qualifications

• 12 years of Manufacturing or Operations experience required.
• Experience directly managing people and leading teams is essential.

Responsibilities

• Supervise a team in the manufacture of GMP drug substances.
• Champion a safe and compliant production environment.

Skills

Leadership

Team Building

Problem Solving

Communication Skills

Conflict Resolution

Education

High School Diploma / GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

Microsoft Office

EBR/MES

Delta V

Electronic Quality Systems

Job description

Front Line Manufacturing Manager (Downstream) - Night shift

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 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.

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 manufacturing, specifically in the area of downstream manufacturing. The initial schedule will be Monday-Friday 10-hour days and may include work from home. The schedule will transition to a day or night shift (12-hour rotation) upon completion of startup activities.

As a manufacturing leader, you will supervise a team 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 reinforce these principles onto the manufacturing floor.

Through your leadership, you will lead all aspects of teams in technical, on-the-floor operations in a biotechnology drug substance operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship.

All front-line managers 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

1. Compliance:
   1. Ensure safe working environment
   2. Ensure cGMP and CFR compliance of operating areas
   3. Ensure Amgen policies are followed
   4. 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 advised prior to the changes
   5. Interact with regulatory agencies as needed
   6. Assure proper gowning and aseptic techniques are followed
2. Staff Supervision:
   1. Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
   2. Responsible for selection, training, evaluation, and development of staff
   3. Mentor and coach staff members to live by the Amgen Values
   4. Develop and implement training plans and programs, to ensure staff are prepared and compliant
   5. Ensure adherence to production schedule and maintenance activities
   6. Interacts with management in optimizing organizational structure and responsibilities
   7. Ensure plant safety through auditing, evaluations, and cross functional walks
   8. Ensure gowning and aseptic technique training programs are maintained
3. Process/Equipment/Facilities:
   1. Demonstrate technical proficiency in manufacturing processes
   2. Collaborate with cross-functional teams (i.e. QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities
   3. Develop, implement and assess CAPA’s and solutions to complex problems
   4. Responsible for elevating and resolving problems during daily operations
   5. Oversees set up, execution and completion of critical manufacturing processes
4. Administrative:
   1. Interacts with management in planning, developing and maintaining budget

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The leading professional we seek has management experience along with these qualifications.

Basic Qualifications:

1. High school diploma / GED and 12 years of Manufacturing or Operations experience OR
2. Associate’s degree and 10 years of Manufacturing or Operations experience OR
3. Bachelor’s degree and 5 years of Manufacturing or Operations experience OR
4. Master’s degree and 3 years of Manufacturing or Operations experience OR

And

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

1. Bachelor’s degree in Life Sciences or Engineering
2. Experience in biotechnology or pharmaceutical plant start up
3. Basic understanding of downstream purification operations (Chromatography, TFF, Viral Filtration) within a Biotechnology Drug Substance Manufacturing facility
4. 5+ years of knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
5. 3+ years of experience in a production area Lead, Specialist or Manager role
6. Strong leadership and teambuilding skills (coaching, mentoring, counseling)
7. Experience with performance management including performance reviews
8. Conflict Resolution, analytical problem solving, and project management skills
9. Detailed understanding of regulatory requirements
10. Excellent verbal and written communication (technical) skills
11. Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.