Front Line Manufacturing Manager (Downstream)
Company: Amgen
Location: Holly Springs
Posted on: March 14, 2026
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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) Live 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. Asamanufacturingleaderyou will overseeteamsof
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.
Responsibilities 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 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
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 Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com AmgenNorthCarolina
Keywords: Amgen, Durham , Front Line Manufacturing Manager (Downstream), Manufacturing , Holly Springs, North Carolina