Address
SalaryHOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Specialist Manufacturing, New Product Introductions
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will work as a Manufacturing Specialist supporting New Product Introductions (NPI) as part of the Building 20 NPI team within the Drug Product Supply organization in Amgen Thousand Oaks.
This role serves as a Technology Transfer lead for New Product Introductions (NPI) into the Drug Product manufacturing facility. The specialist will function as the site interface between the Product Delivery Teams (PDT’s) and Process Engineering (sending site role), and Building 20's Drug Product Manufacturing Team (receiving site role). A high degree of interaction is required with key functional groups, for example, Scheduling, Supply Chain, Quality, Process Engineering, Process Development, PDT teams and other supporting groups. Candidates will need to demonstrate process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled. The candidate will be responsible for leading projects to deliver NPIs on time, and have proven strong communication and collaborative capabilities, both within and outside of the immediate team.
The Manufacturing Specialist will be primarily responsible for:
Working with various NPI support groups to develop, maintain, and implement the NPI project plan(s). Specialist will function as the NPI lead and is accountable for NPI scope, schedule, risk management and leading through influence to meet NPI project milestones.
Resolving issues in a timely manner and elevating customer concern to various levels of management as appropriate.
Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right-First-Time approach.
Pro-actively leading cross-functional team meetings, to ensure NPI project(s) stay on-track
Succinctly communicating verbally and in writing to staff and leadership
Additional Responsibilities include:
Engaging with Regulatory to ensure alignment & compliance with Regulatory Body Submissions while delivering NPI project(s).
Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned, and presentation to management when appropriate.
Reviewing protocols for manufacturing activities.
Liaising with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licenses.
Identifying improvement opportunities within the organization and taking pro-active steps to build consensus to implement those opportunities.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree in Engineering, Biology, Chemistry or Life Science Field & 2 years of directly-related GMP manufacturing experience OR
Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field & 4 years of directly-related GMP manufacturing experience OR
Associate’s degree & 8 years of directly-related GMP manufacturing experience OR
High school diploma / GED & 10 years of directly-related GMP manufacturing experience
Preferred Qualifications:
Project Management experience advantageous
Understanding of Drug Product Formulation and Vial/Syringe Filling operations
Experience leading cross-functional teams
Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
Independent, self-motivated, able to multi-task in a fast-paced environment
Team-player
Demonstrated flexibility and ability to manage change
Direct experience with regulated environments (e.g., cGMP etc.)
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.
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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.
