Senior Manager Manufacturing Support

Join Amgen's Mission of Serving Patients

At Amgen, we believe in the power of our mission—to serve patients living with serious illnesses—and it drives everything we do. Since 1980, we've been pioneering in the world of biotech, focusing on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients by researching, manufacturing, and delivering innovative medicines to help people live longer, fuller, and happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team.

Senior Manager Manufacturing Support

In this role, you will be responsible for leading and managing the process owners at the ANA Assemble and Packaging Plant. The process owners are responsible for documentation (SOP, PTC, FORM, Manufacturing Procedure), QMS records (Deviation, CAPA, Change Control, CAPA EV), Electronic Batch Records and Risk Assessments. Reporting to the Executive Director Plant Manager, this role will support the other functional areas Assembly and Packaging (Vials, Syringes, Devices), Engineering, Process Development, Quality, Validations, IS, Regulatory and other functions as required. This role is crucial for ANA's success, it is a key contributor in ANA's daily operation and is considered part of the Leadership Team.

Technical

• Manage the manufacturing process owner team that provides technical, project, emergency response, and troubleshooting support to the manufacturing areas.
• Lead the relevant process owner team to achieve plant goals and objectives.
• Ensure consistent global operational practices are implemented through alignment with standards and continued evaluation of practices by engaging in relevant global networks and teams.
• Explain Assembly and Packaging process to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.)
• Ensure process owner has the ability to own Deviations, Change Controls, CAPAs, CAPA EVs and CDOCS documents (Quality System records & documents)
• Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, etc) that are owned by the process owners.
• Support the plant in the project approval, prioritization and implementation process.
• Develop functional area metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.
• Provide technical direction to the team.
• Provide on-the-floor & hands–on support in complex troubleshooting exercises.

Planning

• Lead in the development of the Process Owner's long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals.
• Ensure the coordination and goal alignment of functional area and plant production operations.
• Participate in Plant Level Work Center Team (WCT) Meeting and Lead Process Owners' daily WCT.
• Develop plans and ensure adequate staffing and knowledge to ensure Target Dates for the team's work (NPI, CAPA, Change Control, SOP and EBR revision, risk assessments, etc.) are met.
• Develop, control, maintain, track, justify and stay within the functional area budget.

Support Functions

• Collaborate with and serve as department liaison to support other organizations (Manufacturing, QA, F&E, PD, IS, etc.)
• Resolve issues between manufacturing, quality and maintenance organizations.

Compliance

• Ensure Assembly and Packaging practices (processes & methods) and policies align with external regulatory requirements and internal corporate and site guidelines and procedures.
• Connect with Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance.
• Develop, approve, establish and ensure practices and policies are consistent.
• Main Manufacturing point of contact in regulatory audits.
• Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area.

Staff

• Coach, mentor and ensure the development of supervisors and staff.
• Partner with HR to recruit, retain and empower staff.
• Ensure an ongoing organizational structure capable of adapting to changing business needs.
• Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs.
• Ensure functional area staff exemplifies the Amgen Values & Behaviors.
• Ensure an executable Succession Plan is in place for the relevant functional area.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Sr Manager Manufacturing Support professional we seek is a leader with these qualifications:

Basic Qualifications:

Doctorate degree and 2 years of manufacturing support experience

or

Master's degree and 6 years of manufacturing support experience

or

Bachelor's degree and 8 years of manufacturing support experience

or

Associate's degree and 10 years of manufacturing support experience

or

High school diploma / GED and 12 years of manufacturing support experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:

• Educational background in Life Sciences or Engineering
• Availability to support the manufacturing operation on Non Standard Shifts, Nights or Weekends (On call and/or on site) as needed
• Experience with Drug Product manufacturing technologies / equipment, specifically Assembly and Packaging manual and automated equipment
• Regulatory knowledge and interactions
• Knowledge of conflict resolution and negotiating skills
• Ability to partner with other departments / functions / areas
• Analytical problem solving
• Considerable organizational skills
• Technical writing and presentation skills.
• Basic project management skills.
• Knowledge of control charting and statistics
• Experience in coaching, mentoring and counseling
• Ability to deal with and manage fast and constant change
• Ability to set goals
• Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately
• Customer satisfaction mentality
• Ample knowledge of cGMP Regulations around Sterile Product Manufacturing, Combination Products and other relevant area regulatory requirements
• Ability to maintain an environment and culture of operational excellence and continuous improvement
• Proven experience implementing a continuous improvement program based on performance monitoring through KPIs
• Desire to create an environment with Diversity, Inclusion and Belonging

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 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