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

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Flexible work models

Competitive benefits

Job summary

Amgen is seeking a Manager Manufacturing (Downstream) for the Night Shift in Holly Springs, NC. You will lead frontline manufacturing teams, ensure safe, compliant 24/7 operations, and drive Lean improvements across downstream processes.

The role emphasizes coaching, staffing, and coordinating cross-functional activities with QA/QC, E&F, PPIC, and Regulatory to meet production goals. Strong leadership and cGMP knowledge are essential.

Qualifications

• Doctorate degree OR Master’s degree with Manufacturing or Operations experience OR Bachelor’s degree with Manufacturing or Operations experience OR Associates degree with Manufacturing or Operations experience OR High school diploma with Manufacturing or Operations experience.
• AND Previous managerial experience directly managing people and/or leading teams, projects, programs or directing the allocation of resources

Responsibilities

• Lead and oversee 24/7 manufacturing operations on the Downstream area with a 12-hour 2-2-3 schedule.
• Coach, mentor and develop staff; hire, train and evaluate team members to sustain a compliant production environment.
• Define area objectives, identify improvement opportunities, and drive Lean and continuous improvement projects.
• Collaborate with QA/QC, F&E, PPIC, Mfg, PD, Regulatory to complete production activities.
• Ensure adherence to production schedules and change control processes.

Skills

Leadership

Manufacturing ops

Lean/CI

cGMP knowledge

Regulatory awareness

Cross-functional

Education

Doctoral degree

Master’s degree

Bachelor’s degree

Associates degree

High school diploma

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic quality systems

Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experience,and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The AmgenFleXBatch facilitycombinesthe latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility not only featuresthe best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integratessustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Manager Manufacturing(Downstream)- Night Shift

What you will do

Letsdo this.Letschange the world. Inthesevital anddynamicrolesyou will beanon-shift front line manager in manufacturing.Theworkingscheduleis based onaday or night shift (12-hour)rotation.

The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am.

Asamanufacturingleaderyou will oversee teamsof manufacturing associateswith differing levels of experience who willberesponsible forthe manufacture of GMP drugsubstances.Through structured onthefloor presence, youwillchampion a safe and compliant production environment.Asan active participant and role model inaLean and continuous improvementculture,the manager willimbedtheseprinciplesonto the manufacturing floor.

Through your leadership, you willoverseeteams intechnical,on thefloor operations ina biotechnologyproduction operation.In addition, you will supportthe developmentof your staff throughcoaching, hiring, andmentorship.

Font-lineManagerwillassistin defining areaobjectives,identifyingimprovement opportunities, and leading change efforts; effectively directing their team anddeliveringshort-and long-termAmgen Operational goals.

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, evaluate,coachanddevelopstaff
• 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 auditing,evaluations, 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, PPIC,Mfg, PD, Regulatory, etc.) in completing production activities
• Develop,implementand assessCAPAs andsolutionstocomplex problems
• Responsible forelevating andresolving problems duringdailyoperations
• Oversees set up, execution,and completion of critical manufacturing processes/tasks

Administrative

• Interacts with management in planning,developingandmaintainingbudget
• 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
• 5+years 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 Resolution,analytical problem solving,and 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