Specialist Contract Development

4 weeks ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Contract Development & Manufacturing

Live

What you will do

Lets do this Lets change the world

Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.

  • Manufacturing operations:Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.

  • Site performance monitoring:Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.

  • Project Management and Technology transfers:Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborator with these qualifications.

    Basic Qualifications:

  • High school diploma / GED and 10 years of Manufacturing experience OR

Associates degree and 8 years of Manufacturing experience OR

Bachelors degree and 4 years of Manufacturing experience OR

Masters degree and 2 years of Manufacturing experience OR

Doctorate degree

Preferred Qualifications:

Bachelors in Business Administration, Engineering, or Science-related field.

5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.

5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.

2+ years of project management experience leading multi-functional and/or multi-location team.

1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.

Manufacturing and cGMP knowledge / experience.

Financial knowledge and business acumen.

Budget management, including purchase orders, financial forecasting, and adhering to financial targets and systems.

Demonstrated matrix management and influencing skills.

Demonstrated negotiation skills.

Operational Excellence proficiency and ability to drive continuous improvement.

Proficient project management skills.

Problem-solving and critical thinking.

Understanding of contractual requirements.

Technical writing and multi-level communication skills.

Demonstrated ability to lead effectively in collaborative/team environment.

Demonstrated ability to take initiative, drive action, and work under minimum supervision.

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.

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