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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.
Senior Manager Manufacturing Support
What you will do Lets do this. Lets change the world. 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 ANAs success, it is a key contributor in ANAs 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 & handson support in complex troubleshooting exercises Planning
Lead in the development of the Process Owners 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 teams 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
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
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, 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. careers.amgen.com
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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info Website http://careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States
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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.
Senior Manager Manufacturing Support
What you will do Lets do this. Lets change the world. 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 ANAs success, it is a key contributor in ANAs 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 & handson support in complex troubleshooting exercises Planning
Lead in the development of the Process Owners 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 teams 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
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
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, 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. careers.amgen.com
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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info Website http://careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States
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