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
Master’s degree and 3 years of manufacturing and operations experience OR
Bachelor’s degree and 5 years of manufacturing and operations experience OR
Associate’s 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, 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-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
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.
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.
