Sr Manufacturing Manager - Continuous Improvement

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Manufacturing Manager - Continuous Improvement

What you will do

Lets do this. Lets change the world. At Amgen we are committed to being science-based and follow a continuous learning approach to advancing science driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for leading and managing continuous improvement projects at the AOH Assemble and Packaging Plant. Includes revision of 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 AOH success it is a key contributor in AOH daily operation and is considered part of the Leadership Team.

Technical

• Manage the manufacturing Continuous Improvement team that provides technical project and troubleshooting support to the manufacturing areas.
• Lead the relevant continuous improvement 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.)
• Oversee the development revision review and approval of documents (SOPs FORMS Deviations CAPAs CC etc) that are owned by the continuous improvement team
• 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 & handson support in complex troubleshooting exercises
• Leads strategy on OEE improvements
• Leads Yellow and Green Belt Manufacturing initiatives

Planning

• Lead in the development of the Continuous Improvement teams 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 daily WCT
• Develop plans and ensure adequate staffing and knowledge to ensure Target Dates for the teams work (NPI CAPA Change Control SOP and EBR revision risk assessments etc.) are met

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
• 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

Doctorate degree and 2 years of manufacturing support experience

or

Masters degree and 6 years of manufacturing support experience

or

Bachelors degree and 8 years of manufacturing support experience

or

Associates degree and 10 years of manufacturing support experience

or

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

2 years of experience managing people and/or leadership experience leading teams projects and programs or directing the allocation of resources

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 Final 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 well 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-off plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen anticipates accepting applications until 6/30/2025; however we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.

Salary Range