AddressHOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Manager, Manufacturing Support
Live
What you will do
Let’s do this. Let’s change the world. This role will support the manufacturing team to assure product is produced “Right First Time” and to the highest standard of quality to align with regulatory requirements. This position requires a strong, collaborative nature while also working as a proactive, autonomous subject matter expert.
In this role, you will manage a team of manufacturing senior associates (technical writers) and provide technical expertise and oversight of developing, reviewing, and maintain the lifecycle of manufacturing documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.
Not only will the Manager, Manufacturing play a key role in technical writing, but will also provide expertise in the Quality Management System (QMS) at Amgen. This will include QMS process implementation and execution on deviations, CAPAs, and change controls.
Responsibilities may include, but are not limited to:
Lead the team responsible for lifecycle management of manufacturing documentation in DMS.
Oversee the creation and/or revision of controlled documents, including SOPs, WI, technical reports, and training materials.
Ensure documentation-related activities are completed accurately, timely, and remain current.
Lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management.
Optimize staff responsibilities and organizational structure to ensure effective project planning and execution.
Collaborate with cross-functional teams to ensure GMP standards are in-line with current operating systems.
Support Amgen through continuous improvement and process improvement initiatives.
Provide training and support to colleagues.
Support audits and inspections, which may include direct interaction with regulatory agencies.
Drive lean transformation and operational excellence initiatives.
Build and maintain strong relationships within the Amgen Network to share standard processes and align on streamlined initiatives.
Win
What we expect of you
Master’s Degree in Science, Engineering, or an equivalent technical field with an additional 3 years of Manufacturing, Packaging, or Quality career experience
Basic Qualifications:
Doctorate degree
OR
Master’s Degree in Science, Engineering, or an equivalent technical field with an additional 3 years of Manufacturing, Packaging, or Quality career experience
Or
Bachelor's Degree in Science, Engineering, or an equivalent technical field with an additional 5 years of Manufacturing, Packaging, or Quality career experience
Or
Associate’s Degree in Science, Engineering, or an equivalent technical field with an additional 10 years of Manufacturing, Packaging, or Quality career experience
Or
High school diploma / GED and 12 years of Manufacturing, Packaging, or Quality career experience
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 working in pharmaceutical and/or biotechnology industry.
Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
Experience in leading or supporting deviations, investigations, CAPA’s and change controls.
Experience with device assembly and packaging of final product.
Ability to translate highly technical information into easily understandable information for manufacturing operators.
Leader in problem solving and making risk-based decisions to maintain quality and compliance.
Experience with Regulatory agencies.
A fact-based problem solver with strong troubleshooting and problem-solving skills.
Pro-active, result driven, and ability to prioritize work to meet deadlines.
Thrive
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.
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.
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, 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 and bi-annual company-wide shutdowns
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
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.
