Specialist Contract Development & Manufacturing

Amgen • Thousand Oaks, CA

3d

About The Position

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. Specialist Contract Development & Manufacturing What you will do Let’s do this! Let’s 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. 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.

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

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• health and welfare plans for staff and eligible dependents
• financial plans with opportunities to save towards retirement or other goals
• work/life balance
• 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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED