Associate Manufacturing – Downstream - Nights Job at Amgen (Holly Springs)

Associate Manufacturing – Downstream - Nights

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
Bachelor’s Degree
Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions
Perform documentation for assigned functions (i.e., equipment logs, EBRs)

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Associate Manufacturing - Downstream - Nights

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree
Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Associate Manufacturing - Downstream - Nights

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree
Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate's Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor's Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree

Job Responsibility

Completes work in accordance with established cGMP procedures and policies
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations

What we offer

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

Fulltime

Associate Manufacturing - Nights

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , West Greenwich

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 2 years of manufacturing or operations work experience
Associate’s + 6 months of manufacturing or operations work experience
Bachelor’s Degree in a related field

Job Responsibility

Perform operations in Manufacturing (AR30), specifically in downstream operations
Perform and monitor critical processes associated with protein purification while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) and batch records
Perform in-process sampling of drug substance applying analytical equipment
Perform hands-on operations that include inspecting and installing single use components, chromatography operations, UF/DF operations, sample analysis, drug substance fill operations and breaking down vessels
Perform technical writing to draft and revise documents such as Manufacturing Procedures, Deviations, Safety Reporting, and Equipment logs
Conduct basic troubleshooting and assist in the review of documentation for assigned functions
Participate in cross-functional teams to expand technical background in the bio-technologies industry
Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives
Maintain an inspection ready workspace
Organize and maintain material inventory in the manufacturing space

What we offer

Added 15% shift differential
Premium pay for any Sundays worked
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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Front Line Manufacturing Manager (Downstream) - Night Shift

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

111714.00 - 139899.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Oversee teams of manufacturing associates responsible for the manufacture of GMP drug substances
Champion a safe and compliant production environment
Imbed Lean and continuous improvement principles onto the manufacturing floor
Oversee teams in technical, on the floor operations in a biotechnology production operation
Support the development of staff through coaching, hiring, and mentorship
Assist in defining area objectives, identifying improvement opportunities, and leading change efforts
Ensure safe working environment
Ensure Amgen policies are followed, including cGMP and CFR compliance
Evaluate current operating procedures and recommend changes to management to optimize production
Assure all corporate change control procedures are followed

What we offer

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

Fulltime

New

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

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensure safe working environment
Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
Evaluate current operating procedures and recommend changes to management to optimize production
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
Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
Recruit, train, evaluate, coach and develop staff
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

What we offer

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

Fulltime

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensure safe working environment
Ensure Amgen policies are followed, including cGMP and CFR compliance of assigned areas
Evaluate current operating procedures and recommend changes to management to optimize production
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
Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
Recruit, train, evaluate, coach and develop staff
Mentor and coach staff members to live by the Amgen Values
Develop and implement training plans and programs, to ensure staff are prepared and compliant

What we offer

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
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

Fulltime

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