Career CategoryManufacturing
Job DescriptionJoin Amgen's Mission of Serving PatientsAt 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 - AML 1 (Inspection)What you will doLet's do this. Let's change the world! In this vital role, the Front-Line Manager Manufacturing is responsible for leading and supervising either a small manufacturing or a section of a larger production area in an AML1 Inspection-Drug Product organization. You will lead and empower employees to perform a production process to fulfill business goals.
As the leader of the manufacturing floor, you will also provide mentorship, instruction, motivation, and feedback to the employees on a day-to-day basis. Your scheduled workweek may include extended shifts, Saturday and/or Sunday and/or 8/10/12hrs, second or third shift regularly, based on business need.
Specific responsibilities include but are not limited to:- Evaluate and approve reinspection protocols.
- Assure achieve schedule adherence with Supply Chain requirements.
- Ensure cGMP and CFR compliance of operating areas and Amgen policies are followed.
- Ensure that all non-conformances are triage within the established goal, in addition to acting as a lead for Human Performances Deviations. Responsible for handling minor Non-conformances and CAPAs closure within established plans.
- Interact with regulatory agencies for internal and external audits.
- Collaborate with cross-functional teams (i.e. Quality Assurance/Quality Control, Production Planning & Inventory Control (PPIC), Process Development, Regulatory, etc.) in completing production activities.
- Applies analytical skills to identify and solve business and technical problems.
- Responsible for selection, training, performance evaluations, staff relations and development of staff.
- Control and supervise budget area expenses, including meal penalty and overtime.
- Ensure plant safety through auditing and evaluations.
- Lead the process to maintain focus of the group on continuous improvement and the use of ideas initiative or/and kaizen process in the inspection areas.
What we expect of youWe are all different! Yet, we all use our outstanding contributions to serve patients. The Manager Manufacturing professional we seek is a strong 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 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.
Preferred Qualifications:- Experience in the pharmaceutical, medical device, biotechnology, or other regulated industries with proficiency in biopharmaceutical compliance knowledge
- Drug product Inspection operations experience.
- Strong team building & leadership skills, and ability to successfully prioritize a diverse workload to meet targets
- Experience handling Deviations and CAPA
- Verbal and written communication skills in Spanish and English.
- Flexibility, analytical problem-solving, manage change, project management and presentation skills
- Experience with regulated systems to perform job duties (i.e. SAP/MES, QMTS, LMS, LIMS, Maximo, Trackwise, etc.)
What you can expect of usAs 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:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comAs 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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