At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâto serve patients living with serious illnessesâdrives all that we do.
Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ we reach millions of patients each year. As a member of the Amgen team, youâll 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, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Letâs do this. Letâs change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a shift.
Compliance:
Evaluate and approve reports and protocols.
Ensure cGMP and CFR compliance of operating areas.
Revise, update, and review procedures
Manage the development and revision of SOPs.
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 made aware prior to the changes.
Interact with the FDA.
Ensure Amgen policies are followed
Ensure maintenance and re validation of systems.
Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.
Develop, implement and assess solutions for problems.
Responsible for resolving problems during operation.
Coordinates set up of critical new manufacturing processes.
Responsible for selection, training, evaluation, staff relations and development of staff.
Ensure training programs are maintained
Ensure scheduling of production and maintenance activities.
Interacts with management in optimizing organizational structure and responsibilities
Ensure plant safety through auditing and evaluations.
Interacts with management in planning, developing and maintaining budget.
Assist in developing and maintaining department goals
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.
Basic Qualifications:
Doctorate degree
Masterâs degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
Bachelorâs degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.
Associateâs degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry.
High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry.
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, prograns, or directing the allocation or resources. Â Your managerial experience may run concurrently with the required technical experience referenced aboveÂ
Preferred Qualifications:
Educational background in Science, Engineering or Business Administration
Availability to work on a 12-hour PM shift
Strong Managerial skills
Non-Conformance and CAPA
Ensure that all Non-conformance are triage within the established goal.
Leadership and team building
Verbal communication
Written Communication including technical writing skills
Conflict Resolution
Analytical Problem Solving
Project Management
Coaching, Mentoring and Counseling
Ability to be flexible and manage change
Regulatory requirements
Scheduling
Presentation Skills
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, weâll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
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
Flexible work models, including remote and hybrid work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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 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.
.Salary Range
111,714.00 USD - 139,899.00 USDamgen