CrawlJobs Logo

Senior Manufacturing Manager - Downstream

amgen.com Logo

Amgen

Location Icon

Location:
United States , Holly Springs

Category Icon
Category:

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

136227.80 - 184308.20 USD / Year

Job Description:

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. 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 Amgen FleXBatch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Manager: Manufacturing Live What you will do Let’s do this. Let’s change the world. As a Senior Manager of Manufacturing, you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in downstream purification. In this vital role as a member of the Manufacturing leadership team, the Sr. Manager of Manufacturing will collaborate cross-functionally to enable the GMP to manufacture drug substance in a new manufacturing facility. This role is responsible for coaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production. Additionally, you will be accountable for organizational design of the manufacturing team, hiring and development of staff, and ensure staff is compliant with training programs to support safe and reliant operations. The position will also provide leadership and oversight for operational readiness activities to ensure successful facility start-up and sustained manufacturing performance.

Job Responsibility:

  • Develop and retain a diverse and high performing team in alignment with operational readiness schedules to ensure successful startup and commercial GMP operations
  • Mature the site's safety and quality culture of the department and champion continued improvement
  • Collaborate as one team of all manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners)
  • Provide support to troubleshoot, identify, and resolve issues as needed and manage call coverage for 24/7 operation
  • Provide technical leadership for the investigation of deviations and the development of corrective actions
  • Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement
  • Lead and support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections
  • Deliver against organizational financial commitments while championing a lean philosophy

Requirements:

  • Doctorate degree and 2 years of Manufacturing & Operations experience
  • Master's degree and 6 years of Manufacturing & Operations experience
  • Bachelor's degree and 8 years of Manufacturing & Operations experience
  • Associate's degree and 10 years of Manufacturing & Operations experience
  • High School diploma/GED and 12 years of Manufacturing & Operations experience
  • 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice to have:

  • Demonstrated managerial experience in a GMP manufacturing drug substance plant
  • Demonstrated experience in applying Operational Excellence and Lean Manufacturing
  • Cross-functional work experience in either Process Development, Quality or Engineering
  • Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
  • Demonstrated ability to forge and maintain strong relationships with other functional areas
  • Ability to effectively develop and coach staff and positively advance the culture of an organization
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Manufacturing Manager - Downstream

Senior Advanced Manufacturing Engineering Manager

At Formlabs, we’re building the tools that make it possible for anyone to bring ...
Location
Location
United States , Somerville
Salary
Salary:
120000.00 - 225000.00 USD / Year
formlabs.com Logo
Formlabs GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. degree in engineering
  • mechanical, manufacturing engineering, aerospace, industrial, or related/equivalent field
  • 3+ years experience in an engineering management or engineering team leadership role
  • 5+ years of technical skills, preferably experience in manufacturing engineering roles for complex electro-mechanical product industrialization at scale, including machined, sheet metal, injection molded, PCBA, linear motors, LCD, cables, and plastic components
  • Experience with remotely managed NPI and contract manufacturers, including transitioning high accuracy products from prototype to mass production
  • Expertise in production quality metrics, GD&T, and process/equipment qualification procedures
  • Proficient in methods for statistical analysis (e.g. DOE, comparison testing, Gage R&R), structured problem solving (e.g. A3, 8D, DMAIC), fault-tree), and process control (e.g. statistical process control, process capability Cp/Cpk)
  • Willing to work onsite, in a fast paced environment, and occasionally coordinate with colleagues in different time zones during late evening local hours
  • Travel to vendors, suppliers, and production facilities (mostly in China) from time to time (~10-20%)
Job Responsibility
Job Responsibility
  • Lead the activities of a team of manufacturing engineering professionals responsible for supporting an extended team of global manufacturing, supply chain, quality professionals
  • Ongoing sustainment of manufacturing lines at our contract manufacturers + transition into production and support
  • Characterize process & product failures on our manufacturing line, root cause investigations, corrective actions, and mistake-proofing at suppliers and contract manufacturers for component/module/product new builds and refurbishments
  • Own manufacturing process (e.g. assembly, printer calibration, verification testing, etc.) control and issue prevention
  • implementing tools, equipment and process methods to ensure industry-leading reliability, quality, and yield
  • Drive team collaboration and support across projects/programs as a player coach on complex engineering and operational challenges
  • Own manufacturing technical readiness as a critical member of our cross-functional NPI teams, with specific emphasis on manufacturing return of experience, producibility, cost effectiveness, industrialization
  • negotiate conflicting requirements, identify lessons-learned and DFM/DFA/DFSS opportunities and share/escalate to upstream design engineers and downstream sustaining engineers
  • Manage the details of transition into manufacturing or industrialization, including resolution of first article inspections (FAI) and product/fixture assembly issues
  • drive maturity of manufacturing readiness
What we offer
What we offer
  • Robust equity program to build future wealth through RSUs
  • Comprehensive healthcare coverage (Medical, Dental, Vision)
  • Low cost fund options in our 401K and access to advisors
  • Generous paid Parental Leave (up to 16 weeks)
  • Tenure-based paid Sabbatical Leave (up to 6 weeks)
  • Flexible Out of Office Plan – Take time when you need it
  • Ample on-site parking & pre-tax commuter benefits
  • Healthy on-site lunches, snacks, beverages, & treats
  • Regular sponsored professional development opportunities
  • Many opt-in culture events across our diverse community
  • Fulltime
Read More
Arrow Right

Senior Advanced Manufacturing Manager

Do you want to change how the world creates? At Formlabs, we’re building the too...
Location
Location
United States , Somerville
Salary
Salary:
120000.00 - 225000.00 USD / Year
formlabs.com Logo
Formlabs GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. degree in engineering
  • mechanical, manufacturing engineering, aerospace, industrial, or related/equivalent field
  • 3+ years experience in an engineering management or engineering team leadership role
  • 5+ years of technical skills, preferably experience in manufacturing engineering roles for complex electro-mechanical product industrialization at scale, including machined, sheet metal, injection molded, PCBA, linear motors, LCD, cables, and plastic components
  • Experience with remotely managed NPI and contract manufacturers, including transitioning high accuracy products from prototype to mass production
  • Expertise in production quality metrics, GD&T, and process/equipment qualification procedures
  • Proficient in methods for statistical analysis (e.g. DOE, comparison testing, Gage R&R), structured problem solving (e.g. A3, 8D, DMAIC), fault-tree), and process control (e.g. statistical process control, process capability Cp/Cpk)
  • Willing to work onsite, in a fast paced environment, and occasionally coordinate with colleagues in different time zones during late evening local hours
  • Travel to vendors, suppliers, and production facilities (mostly in China) from time to time (~10-20%)
Job Responsibility
Job Responsibility
  • Lead the activities of a team of manufacturing engineering professionals responsible for supporting an extended team of global manufacturing, supply chain, quality professionals
  • Ongoing sustainment of manufacturing lines at our contract manufacturers + transition into production and support
  • Characterize process & product failures on our manufacturing line, root cause investigations, corrective actions, and mistake-proofing at suppliers and contract manufacturers for component/module/product new builds and refurbishments
  • Own manufacturing process (e.g. assembly, printer calibration, verification testing, etc.) control and issue prevention
  • implementing tools, equipment and process methods to ensure industry-leading reliability, quality, and yield
  • Drive team collaboration and support across projects/programs as a player coach on complex engineering and operational challenges
  • Own manufacturing technical readiness as a critical member of our cross-functional NPI teams, with specific emphasis on manufacturing return of experience, producibility, cost effectiveness, industrialization
  • negotiate conflicting requirements, identify lessons-learned and DFM/DFA/DFSS opportunities and share/escalate to upstream design engineers and downstream sustaining engineers
  • Manage the details of transition into manufacturing or industrialization, including resolution of first article inspections (FAI) and product/fixture assembly issues
  • drive maturity of manufacturing readiness
What we offer
What we offer
  • Robust equity program to build future wealth through RSUs
  • Comprehensive healthcare coverage (Medical, Dental, Vision)
  • 401K matching and access to financial advisors
  • Generous paid Parental Leave (up to 16 weeks)
  • Tenure-based paid Sabbatical Leave (up to 6 weeks)
  • Flexible Out of Office Plan – Take time when you need it
  • Ample on-site parking & pre-tax commuter benefits
  • Healthy on-site lunches, snacks, beverages, & treats
  • Regular sponsored professional development opportunities
  • Many opt-in culture events across our diverse community
  • Fulltime
Read More
Arrow Right

Senior Advanced Manufacturing Manager

Do you want to change how the world creates? At Formlabs, we're building the too...
Location
Location
United States , Boston
Salary
Salary:
120000.00 - 225000.00 USD / Year
formlabs.com Logo
Formlabs GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. degree in engineering
  • mechanical, manufacturing engineering, aerospace, industrial, or related/equivalent field
  • 3+ years experience in an engineering management or engineering team leadership role
  • 5+ years of technical skills, preferably experience in manufacturing engineering roles for complex electro-mechanical product industrialization at scale, including machined, sheet metal, injection molded, PCBA, linear motors, LCD, cables, and plastic components
  • Experience with remotely managed NPI and contract manufacturers, including transitioning high accuracy products from prototype to mass production
  • Expertise in production quality metrics, GD&T, and process/equipment qualification procedures
  • Proficient in methods for statistical analysis (e.g. DOE, comparison testing, Gage R&R), structured problem solving (e.g. A3, 8D, DMAIC), fault-tree), and process control (e.g. statistical process control, process capability Cp/Cpk)
  • Willing to work onsite, in a fast paced environment, and occasionally coordinate with colleagues in different time zones during late evening local hours
  • Travel to vendors, suppliers, and production facilities (mostly in China) from time to time (~10-20%)
Job Responsibility
Job Responsibility
  • Lead the activities of a team of manufacturing engineering professionals responsible for supporting an extended team of global manufacturing, supply chain, quality professionals
  • Ongoing sustainment of manufacturing lines at our contract manufacturers + transition into production and support
  • Characterize process & product failures on our manufacturing line, root cause investigations, corrective actions, and mistake-proofing at suppliers and contract manufacturers for component/module/product new builds and refurbishments
  • Own manufacturing process (e.g. assembly, printer calibration, verification testing, etc.) control and issue prevention
  • implementing tools, equipment and process methods to ensure industry-leading reliability, quality, and yield
  • Drive team collaboration and support across projects/programs as a player coach on complex engineering and operational challenges
  • Own manufacturing technical readiness as a critical member of our cross-functional NPI teams, with specific emphasis on manufacturing return of experience, producibility, cost effectiveness, industrialization
  • negotiate conflicting requirements, identify lessons-learned and DFM/DFA/DFSS opportunities and share/escalate to upstream design engineers and downstream sustaining engineers
  • Manage the details of transition into manufacturing or industrialization, including resolution of first article inspections (FAI) and product/fixture assembly issues
  • drive maturity of manufacturing readiness
What we offer
What we offer
  • Robust equity program to build future wealth through RSUs
  • Comprehensive healthcare coverage (Medical, Dental, Vision)
  • 401K matching and access to financial advisors
  • Generous paid Parental Leave (up to 16 weeks)
  • Tenure-based paid Sabbatical Leave (up to 6 weeks)
  • Flexible Out of Office Plan – Take time when you need it
  • Ample on-site parking & pre-tax commuter benefits
  • Healthy on-site lunches, snacks, beverages, & treats
  • Regular sponsored professional development opportunities
  • Many opt-in culture events across our diverse community
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing - Downstream - Nights

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing - Downstream - Nights

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing - Bulk Drug Substance Downstream

Let’s do this. Let’s change the world. In this dynamic role, you will be a Senio...
Location
Location
United States , Holly Springs
Salary
Salary:
86048.05 - 116417.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master's Degree
Job Responsibility
Job Responsibility
  • Execute on-the-floor operations within manufacturing in accordance with cGMP practices
  • Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
  • Initiate quality non-conformance (NC) reports
  • Assure proper gowning and aseptic techniques are always followed
  • Perform hands-on downstream biotech operations 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
  • Complete washroom activities
  • Initiate and own manufacturing related process deviations
  • Identify, recommend, and implement innovative process improvements and optimizations
  • Fulltime
Read More
Arrow Right
New

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Location
Location
United States , Holly Springs
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Director, Manufacturing Execution

In this vital role you will be accountable for leading all drug substance manufa...
Location
Location
United States , Holly Springs
Salary
Salary:
190965.00 - 225559.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of manufacturing experience
  • Master’s degree and 8 years of manufacturing experience
  • Bachelor’s degree and 10 years of manufacturing experience
  • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Job Responsibility
Job Responsibility
  • Provide strategic and operational leadership for all execution activities across Upstream, Downstream, and Services operations within the FleX Batch facility
  • Ensure safe, compliant, and reliable manufacturing of drug substance in accordance with cGMPs, regulatory commitments, and Amgen Quality standards
  • Own performance across key operational metrics including Safety, Quality (RFT, deviations, CAPA effectiveness), Delivery (schedule adherence, campaign execution), Cost, and People
  • Ensure robust daily management systems are in place to monitor performance, identify gaps, and drive timely escalation and resolution
  • Partner cross-functionally with Process Development, Manufacturing Support, Quality, Supply Chain, Engineering, Maintenance, and Digital to ensure seamless execution of production campaigns
  • Drive a culture of disciplined execution and continuous improvement
  • Champion right-first-time performance and reduction of deviations, human performance errors, and process variability
  • Leverage Industry 4.0 digital tools, automation, and data analytics to enhance process robustness and decision-making
  • Support facility start-up, technology transfers, validation activities, and lifecycle management of products manufactured within the FleX Batch facility
  • Ensure operational readiness for new product introductions, capacity expansions, and process improvements
What we offer
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
Read More
Arrow Right