HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Front-Line Manufacturing Manager (Non-Standard Shift - Night Shift)
What you will do
Lets do this. Lets change the world! In this vital role the Front-Line Manufacturing Manager is responsible for leading and supervising either a small manufacturing or a section of a larger production area in an Inspection and Packaging facility. 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 within a non-standard shift structure. Your scheduled workweek may include extended shifts, Saturday and/or Sunday and/or 12hrs, second or third shift on a regular basis, based on business need. We have two vacancies for this role. Specific responsibilities include but are not limited to:
Evaluate and approve reports and protocols
Assure achieve schedule adherence with Supply Chain requirements
Creates and enforces quality integrity checks and ensure regulatory compliance of operating areas
Ensure that all non-conformances are triage within the established goal, in addition to act as a lead for Human Performances Deviations
Assure corporate change control procedures are followed, and that the Regulatory and Quality Assurance partners are advised prior to the changes
Interact with regulatory agencies for internal and external audits
Ensure maintenance and re-validation of systems
Collaborate with cross-functional teams (i.e. Quality Assurance/Quality Control, Production Planning & Inventory Control (PPIC), Clinical Manufacturing, 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/packaging areas
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strong leader with these qualifications.
Masters degree and 3 years of regulated industry experience
Bachelors degree and 5 years of regulated industry experience
Associates degree and 10 years of regulated industry experience
High school diploma / GED and 12 years of regulated industry experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
Beyond that, additional Preferred Qualifications are:
Experience in the pharmaceutical, medical device, biotechnology or other regulated industries with proficiency in biopharmaceutical compliance knowledge
Strong Managerial skills and ability to successfully prioritize a diverse workload to meet targets
Experience Managing Deviations and CAPA
Verbal and written communication skills in Spanish and English that will include technical terminology
Analytical problem solving, project management and presentation skills
Experience with regulated systems to perform job duties (SAP/MES, QMTS, LMS, Maximo, Trackwise, etc.)
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Apply now for a career that defies imagination
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, 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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.