Specialist Contract Development & Manufacturing Job at Amgen (Thousand Oaks)

Job Description

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility

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

Requirements

High school diploma / GED and 10 years of Manufacturing experience
Associate’s degree and 8 years of Manufacturing experience
Bachelor’s degree and 4 years of Manufacturing experience
Master’s degree and 2 years of Manufacturing experience
Doctorate degree
Bachelor’s 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

What we offer

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 where possible

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Specialist Contract Development & Manufacturing

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