Manager Manufacturing Programs

BioSpace; Thousand Oaks (CA); Vor Ort; USD 121.000 - 163.000; Vollzeit

Benefits dieser Stelle

Competitive benefits

Bonus program

Stock incentives

Flexible work options

Zusammenfassung

Amgen seeks a Manager in drug substance technical operations to lead a team of subject matter experts within the Manufacturing Programs group. You will support new product introduction, technology deployment, and continual improvement across the plant floor and manufacturing systems.

The role blends hands-on execution with strategic leadership, directing GMP document control, change management, and cross-functional collaboration to ensure compliant, efficient operations for clinical and

Qualifikationen

• Doctorate, Masters, or Bachelors with manufacturing/ops experience.
• Experience leading teams, projects, or programs in a GMP environment.
• Direct experience managing people and resources in a manufacturing setting.

Aufgaben

• Lead a team of manufacturing specialists and SMEs in upstream manufacturing.
• Champion continual improvement and manage complex projects.
• Lead readiness of new technologies, equipment, or processes.
• Draft and revise GMP documents (SOPs, Forms) and qualification protocols.
• Handle CAPAs, deviations, cleaning validation and equipment commissioning.
• Collaborate with cross-functional teams to implement area improvements.

Kenntnisse

Leadership

Project management

Cross-functional teamwork

Data analysis

Technical writing

Communication skills

Ausbildung

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Jobbeschreibung

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Manager Manufacturing

What you will do

Lets do this. Lets change the world. In this vital role you will be part of the Manufacturing Programs team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continualimprovement projects, supporting the multiproduct facility operation program, CAPA, deviation investigations, and optimization/implementation of single use technologies. The position is within the drug substance supply organization, a dynamic environment and an important launch point for Amgens pipeline products. The plants we support manufacture drug substances at all phases of clinical trials through commercial production. We are seeking an experienced Manager in drug substance technical operations to lead a team of subject matter experts. The applicant should have experience managing people, projects, leading/performing technology development activities and characterization efforts. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective/preventive actions and implementing them. Some hands-on work on the plant floor executing runs and experiments, working with large-scale equipment, analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices, ensuring documentation accurately reflects operations performed, implementing area improvements, commissioning equipment, design of experiments, effectively communicating findings and participating in operations meetings.

Responsibilities Include

• Leading a team of manufacturing specialists, subject matter experts in upstream manufacturing.
• Demonstrating strategic problem-solving skills and champion continual improvement.
• Managing sophisticated projects using project management skills.
• Lead operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Provide assessment and advice on process impact for changes
• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
• Writing validation protocols and reports in support of cleaning validation, equipment commissioning, qualification, and change management.
• Applying sophisticated process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the detailed delivery of new technologies into the plant.
• Handling Quality Records, such as CCMS, CAPA, and deviations.
• Drafting and revising GMP manufacturing documents (SOPs, Forms)

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 3 years of manufacturing and operations experience OR
• Bachelors degree and 5 years of manufacturing and operations experience OR
• Associates degree and 10 years of manufacturing and operations experience OR
• High school diploma / GED and 12 years of manufacturing and operations experience

In addition to meeting at least one of the above requirements, you must have 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

• Degree in Engineering or Life Sciences
• Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Ability to successfully communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical area
• Ability to drive results through leadership of cross-functional teams
• Experience leading and managing projects and people
• Equipment and Cleaning Validation experience
• Understanding of stainless and single-use technologies
• Excellent writing skills. Presentation experience presentation to leadership or auditors.
• Data analysis and/or data visualization skills
• Availability to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute validation and project tasks with minimal disruption to operations.
• Ability to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.

What you can expect from 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 $120,818.00 to $163,460.00. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.