Front Line Manufacturing Manager (Bulk Drug Substance Downstream) Night Shift

Compliance:

• Ensure safe working environment

• Ensure Amgen policies are followed including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas

• Evaluatecurrent operating procedures and recommend changes to management tooptimizeproduction.

• Assure all corporate change control procedures are followed and Regulatory and QA are notified prior to the changes

• Interact with regulatory agencies as needed

• Assure proper gowning and aseptic techniques are followed

Staff Supervision:

• Engagestaff and build relationships of trust and respect while driving team performance and continuous improvement

• Recruit train evaluatecoachanddevelopstaff

• Mentor and coach staff members to live by the Amgen Values

• Develop and implement trainings plans and programs to ensure staff are prepared and compliant

• Ensure adherence to production schedule and maintenance activities

• Interacts with management inoptimizingorganizational structure and responsibilities

• Ensure plant safety through auditingevaluations and cross functional walks

• Ensure gowning and aseptic techniques training programs are maintained

Process/Equipment/Facilities:

• Demonstrate technical mastery of manufacturing processes

• Collaborate with cross-functional teams (i.e.QA/QC F&E PPICMfg PD Regulatory etc.) in completing production activities

• Developimplementand assessCAPAs andsolutionstocomplex problems

• Responsible forelevating andresolving problems duringdailyoperations

• Oversees set up executionand completion of critical manufacturing processes/tasks

Administrative:

• Interacts with management in planningdevelopingandmaintainingbudget

• Assistin developing andmaintainingdepartment goals

Win

What we expect from you

We are all different yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications.

Basic Qualifications

• Doctoratedegree OR

• Masters degreeand3years ofManufacturing or Operationsexperience OR

• Bachelors degree and5years ofManufacturing or Operationsexperience OR

• Associates degree and 10 years of ManufacturingorOperations experience OR

• High school diploma / GED and 12 years of ManufacturingorOperations experience

• AND Previous managerial experience directly managing people and/or experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications

• Bachelors degree in Life Sciences or Engineering

• Demonstrated strong leadership skills and technical understanding of biotechnology production operations

• Experience inbiotechnology or pharmaceutical plant start up

• Understanding of downstream purification operation (Column Chromatography TFF Viral Filtration Viral Inactivation)

• Previousknowledge and experience within a cGMPenvironment

• 5years process experience in a cGMP manufacturing facility

• 3 years of experience in a production Area Lead Specialist or Manager role

• Strong leadership and teambuilding skills (coaching mentoring counseling)

• Experience with performance management including performance reviews

• Conflict Resolutionanalytical problem solvingand projectmanagement skills

• Thorough understanding of regulatory requirements

• Excellent verbal and written communication (technical) skills

• Excellent computer skills with Microsoft EBR/MES Delta V Electronic quality systems

Thrive

What you can expect of us

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary Amgen offers a Total Rewards Plancomprisinghealth 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models including remote work arrangements where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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