Manager Manufacturing - Cell Culture Ops

them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager Manufacturing - Cell Culture

What you will do

Let's do this. Let's change the world! In this vital role, you will have a meaningful role for the AML6 facility by leading the Upstream day-to-day activities solving operational issues and maintaining the applicable activities in full cGMP compliance.

In addition, you will be accountable for supervising, hiring, and developing staff. Ensuring floor activities are completed on time while meeting safety, quality, and financial objectives. You will also assist the team in delivering training, sharing knowledge, and even may lead responsibilities within the work team.

Specific responsibilities include but are not limited to:

• Management, planning, and oversight of manufacturing functions including the definition of priorities (Know how to run the business).
• Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements.
• Make sure that area staff members are trained to perform assigned production activities.
• Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured.
• Evaluate and maintain an adequate number of personnel who possess the applicable combination of education, experience, and training following cGMP requirements.
• Report and take ownership of non-conformances (deviations) promptly to the Quality and upper management units and investigate per procedures.
• Manage and close corrective actions and preventive actions (CAPA) according to the procedures.
• Ensures the requirements of the Quality Management System are fulfilled.
• Alerts senior manager of critical quality, compliance, supply, and safety risks.
• Provide input for Management Reviews.
• Lead and develop continuous improvement initiatives, programs, and projects.
• Support non-standard shift operations that may include, first, second, third, weekend, and/or 12hrs shifts including extended hours, as per business needs.

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Manager Manufacturing professional we seek is a collaborative leader with these qualifications.

Basic Qualifications:

Doctorate degree

or

Master's degree and 3 years of manufacturing support experience

or

Bachelor's degree and 5 years of manufacturing support experience

or

Associate's degree and 10 years of manufacturing support experience

or

High school diploma / GED and 12 years of manufacturing support experience

And

In addition to meeting at least one of the above requirements, you must have previous managerial 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:

• Mastering Drug Substance -concepts - Upstream experience, for example: experience working and leading large-scale Cell Culture processes, Inoculation preparation, media preparation, solution preparation, testing in MFG pH, Conductivity, Osmolality, Endotoxin, and others.
• Lean Certified and/or experience working in Operational Excellence teams and/or projects.
• Coaching, Mentoring, and Counseling previous experience.
• Flexibility to work different work schedules as per business needs.
• Skills in the following areas: Leadership, leading projects or teams, team building, solving problem-solving, and conflict resolution.
• Verbal and written communication in English and Spanish, including technical writing and Computer literacy that includes SAP, Werum, eBR , Smarsheet, Maximo, LIMS, Trackwise, etc.
• Project Management, scheduling, and presentation experience for different levels/forums.

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.

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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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