Manager Manufacturing - Drug Substance US - Puerto Rico - Juncos

Career Category

Job Description

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.
 

Manager Manufacturing - Drug Substance
 

What you will do

Let’s do this. Let’s change the world! In this vital role you will have a meaningful role for AML7 Drug Substance facility by leading the day to day activities and be accountable for supervising, hiring, and developing staff. Ensuring floor activities are completed on time while meeting safety, quality, and financial objectives.

• Management, planning and oversight of manufacturing functions.
• Ensures that manufacturing facilities, equipment, processes, and procedures are follows cGMP requirements and/or other applicable regulations.
• Make sure that written procedures describing the manufacturing operations are controlled and followed. Also ensuring that area staff are trained to perform assigned production activities.
• Guarantee that the manufacturing activities follow approved cGMP procedures and are documented according to cGMP requirements.
• 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 qualified personnel to execute
• Report deviation to procedures promptly to the Quality unit. Performs as deviation owner (when needed) to complete investigation and closure on time.
• Manage and close corrective actions and preventive actions (CAPA or INCA records) according with the procedures.
• Ensures the requirements of the Quality Management System are fulfilled and provides input for Management Reviews.
• Lead continuous Improvement initiatives, programs and projects.
• Support first, second, third and 12hrs shifts including extended hours, as per business needs.
• Project Management, scheduling and presentation for different levels/forums
   

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 people leader with these qualifications.
 

Basic Qualifications:
 

Doctorate degree
 

OR
 

Master’s degree and 3 years of Manufacturing Support experience in GMP regulated industry
 

OR
 

Bachelor’s degree and 5 years of Manufacturing Support experience in GMP regulated industry
 

OR
 

Associate’s degree and 10 years of Manufacturing Support experience in GMP regulated industry
 

OR
 

High school diploma / GED and 12 years of Manufacturing Support experience in GMP regulated industry
 

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 or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
 

Beyond that, additional preferred qualifications are:

• Education background in Business Administration, Life Sciences and/or Engineering
• Biotech/Pharma industry experience
• Lead or Managerial Manufacturing previous experience
• Lean Certified and/or experience working in Operational Excellence teams and/or projects
• Coaching, Mentoring and Counseling previous experience
• Verbal and written communication in English and Spanish, including technical writing and Computer literacy
   

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

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

careers.amgen.com
 

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.