Senior Manager Manufacturing Programs

Reporting to the Director of Manufacturing Support, this position is responsible...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Process Development, Engineering or Manufacturing experience OR Master’s degree and 6 years of Process Development, Engineering or Manufacturing experience OR Bachelor’s degree and/or 8 years of Process Development, Engineering or Manufacturing experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
In depth business understanding of manufacturing or operations in biotechnology, biopharmaceuticals or pharmaceuticals industry
8+ years of experience in process development, engineering, manufacturing technical support or manufacturing operations
6+ years of leadership experience with two or more years as a cross-functional team leader including experience in performance management, technical problem solving, and managing projects (or equivalent/lateral experience)
4+ years of experience operating in a cGMP environment
Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
Ability to recommend, judge, and make good decisions in complex situations
Ability to responsibly and professionally address difficult business and personnel issues
manage conflict effectively with demonstrated negotiating, partnering and influencing skills

Job Responsibility

Responsible for providing process ownership for multiple biologic/synthetic products as well as introduction of new products into the manufacturing facility
Responsible for overseeing all activities of new product/technology introductions and multi-product campaigns in a compliant, agile and cost-effective manner
Responsible for overseeing all activities associated with cleaning validation and managing the validated state of process equipment
Responsible for contamination control and inspection readiness for manufacturing
Provides direct leadership to production interruption investigation and serve as escalation point for resolving process (including single use)/equipment related issues
Manages deviations, change controls, corrective actions and preventative actions associated with products and process equipment
Manages the implementation and development of the electronic batch records
Drives a culture of continuous improvement
Drives/supports site wide technical and non-technical continual improvement initiatives, programs and projects to increase production and disposition agility
Presents key investigations and quality management system records in site regulatory inspections

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

Fulltime

Senior Manager Manufacturing Systems Engineering

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

Location

United States , Holly Springs

Salary:

148715.15 - 201202.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering
Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus
Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing
Direct knowledge of integrating various OEM automation software and field instrumentation technologies
In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience with Tech Transfer, Process Design, and Commissioning & Qualification

Job Responsibility

Oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs
Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function
Support design reviews while partnering closely with the corporate engineering team
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS)
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls
Provide mentoring to develop and accelerate site technical automation capabilities

What we offer

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

Fulltime

Senior Manufacturing Test Engineer

The Manufacturing Test Engineering team at Block is responsible for making sure ...

Location

Singapore , Singapore

Salary:

Not provided

Block

Expiration Date

Until further notice

Requirements

5+ years of experience in electronics manufacturing
Clear written and spoken English communication skills
Experience working in Python, Labview, or similar programming language
Experience in statistics, and using SQL, JMP, Matplotlib, or similar data visualization programs
Ability to read schematics
Knowledge in circuit design at the “maker” level or beyond (e.g. projects like LED controllers, home automation, weather stations, etc.)
Excited to work on hands-on projects and to make things work in EE, software, and/or ME realms
Experienced with hardware lab equipment for test, measurement (e.g. oscilloscope, power supply, DMM, etc.), and/or prototyping (Raspberry Pi, Arduino, 3D printing, powertools, etc.)
Enthusiastic to apply methodical engineering problem-solving skills to dig into challenges that are outside of your expertise
Able and willing to travel internationally 20% as needed

Job Responsibility

Design, build, and support board-level and product-level functional test stations, including independently debugging and resolving station issues, proactively identifying and implementing improvements, and responding quickly to factory-impacting problems
Serve as the Directly Responsible Individual (DRI) for test stations, owning development, deployment, and ongoing production support
Develop and maintain test station software by autonomously writing, reviewing, and debugging code
implementing robust error handling, logging, and diagnostic capabilities
Analyze test station data and measurements by conducting root cause analysis of test failures, clearly documenting and communicating findings, and proposing and implementing evidence-based solutions
Maintain effective communication with global stakeholders by providing timely updates on status, risks, and blockers
thoroughly documenting technical investigations
and proactively managing and communicating priority changes
Drive continuous improvement by identifying opportunities to enhance test coverage, processes, and systems
taking ownership of issues through resolution

What we offer

Remote work
medical insurance
flexible time off
retirement savings plans
modern family planning

Fulltime

Senior Process Engineer I

As a key hire at the Beam North Carolina site (‘Beam NC’), the Senior Process En...

Location

United States , Durham

Salary:

140000.00 - 160000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS in Chemical Engineering, Bioengineering, Biochemistry, or similar with minimum 5 years of relevant work experience, or a M.S. degree with a minimum of 3 years of relevant work experience
Demonstrated technical expertise within autologous cell therapy, mRNA, and/or LNP therapeutics (experience in CGT manufacturing is preferred), downstream processing for production of large molecule biologics, gene therapy
Experience in single-use systems, closed processing, and aseptic manufacturing techniques
Experience successfully leading manufacturing event investigations, Root Cause Analysis (RCA), and Corrective and Preventative Action (CAPA)
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience
Dynamic interpersonal skills and the ability to manage through influence
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment
Results oriented with the ability to demonstrate resiliency, ownership, and drive
Must be able to work onsite at our Durham, NC facility

Job Responsibility

Act as subject matter expert for CGT equipment and processes in support of cGMP clinical and commercial manufacturing, with focus on the commercialization of Beam’s autologous cell therapy program
Provide Person-In-Plant (PIP) support to manufacturing, as required
Support facility and equipment design and qualification to meet process and regulatory expectations
Lead or contribute to the creation of technical documentation including project documents, equipment preventive maintenance and calibration procedures, process validation plans/protocols/reports, risk assessments, etc
Support deviation and change control generation, review, and execution
Own and manage small CapEx and process improvement projects for the Beam Engineering and Facilities team, and support larger CapEx projects as the process engineering lead
Supports regulatory reviews and responses, audits and regulatory inspections, as required
Represent the Beam NC Engineering & Facilities team within cross functional project teams as required
Establish and maintain strong relationships cross-functionally within the broader Beam Team
Ensure safety, compliance and sustainability throughout the engineering functions

Fulltime

Senior Director, Commercial Product and Vein-to-Vein Systems Operations

Beam is seeking a highly talented and motivated Senior Directory, Commercial Pro...

Location

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree or the combination of education and business experience required
Minimum 10+ years of Quality Management, System Management or Commercial Product Operations in Cell and Gene Therapy
Experience supporting FDA BLA submission, inspection and commercial launch required
Experience building or maintaining traceability portal for cell or gene therapy required
Experience with Treatment Center Qualification and Activation for cell and gene therapy required
Strong direct cell or gene therapy commercial experience within the last 5 years
Ability to work independently with very limited supervision
Ability to navigate and be successful in a fast-paced, highly matrixed work environment
Detail-oriented, able to assess and assimilate data and communicate objectively
Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations

Job Responsibility

Establish and lead cross‑functional governance for commercial product execution, including clear ownership, escalation pathways, and decision rights
Drive readiness for regulatory inspections and audits related to commercial product operations and patient‑specific execution
Partner with Commercial, Patient Operations, Gene Therapy Operations, Quality, Supply Chain, and IT to ensure aligned and disciplined execution from order to infusion
Define and execute the COI/COC validation strategy, including SOPs, workflows, risk assessments, and control points across the full patient journey
Translate FDA, FACT, AABB, and other regulatory requirements into practical, auditable, end‑to‑end workflows
Own COI‑related deviation investigations with commercial impact, partnering with Quality and Operations to resolve issues and prevent recurrence
Design and lead a commercial exceptions management framework covering incoming apheresis material, manufactured drug product, logistics, scheduling, and site readiness issues
Lead investigations, root‑cause analyses, escalation management, and CAPA development across Commercial Product Operations in partnership with Manufacturing, Supply Chain, Quality, and Patient Operations
Provide clear, timely communication of execution risks, trends, and mitigation plans to senior leadership
Serve as the business and product owner for Beam’s workflow and traceability portal, partnering with IT on design, build, validation, and ongoing enhancements

Fulltime

New

Process Analytical Engineer

In this vital role, you will join the Facilities & Engineering (F&E) group and b...

Location

United States , Holly Springs

Salary:

88281.00 - 119439.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 2 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience
OR Associate’s degree and 6 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience
OR High school diploma / GED and 8 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience

Job Responsibility

System ownership, reliability, and operations
Work with the capital project team to ensure systems are installed and operate safely, comply with pertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements
Serve as System Owner and Business Administrator for analytical equipment
Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components
Development of laboratory equipment specifications to use for procurement of new laboratory equipment and instruments
Maintaining a current working knowledge regarding regulatory requirements for equipment qualification and calibration
Support in generation and resolution of protocol discrepancies as required
Alerting Quality Control Management if equipment fails to meet calibration or qualification requirements and conducting impact assessments/investigations as required
Lead the development of calibration/maintenance programs, ensure the availability of spare parts, schedule repairs and maintenance, and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities
Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures

What we offer

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

Fulltime

Supervisor II, Distribution & Logistics

In this hands-on warehouse leadership role, you will be accountable for deliveri...

Location

United States , Charleston

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Strong technical knowledge of logistics and supply chain management, including operational and inventory management judgement, shipping and receiving, and quality control
Proven ability to lead small teams through presence and influence
Comfort operating hands-on on the floor while thinking at a senior level
Strong cross-functional communication and relationship building skills
Working knowledge of ERP/WPS systems (preferably SAP), inventory control, and cycle counting
Ability to operate effectively in a regulated, high-accountability environment
Proficiency in troubleshooting and repairing logistics equipment and systems
Excellent problem-solving and analytical skills
Strong attention to detail and ability to work independently or as part of a team
Bachelor's Degree with 5+ years of progressive warehouse or operations leadership experience, including inventory control ownership OR High School Diploma/GED with 8+ years of progressive warehouse leadership experience, including senior-level accountability in a hands-on role

Job Responsibility

Review upcoming shipments aligned with customer requirements for orders not yet finalized or built and collaborate with Manufacturing and Planning to ensure product availability for timely shipment
Own end-to-end warehouse execution, including receiving, storage, picking, shipping, material handling, goods movement, transportation, and inventory control, with a strong hands-on presence on the floor
Lead and develop a small team of warehouse leads and associates, setting clear expectations, reinforcing accountability, and coaching for consistent performance
Drive performance against warehouse KPI’s including inventory accuracy, cycle count performance, service level, backorders, safety, and compliance
Actively work alongside the team as needed to remove barriers, resolve issues, and ensure critical priorities are met—especially during volume spikes, constraints, or high-risk execution windows
Build and sustain strong cross-functional partnerships with: Quality to ensure compliance, audit readiness, and timely resolution of inventory or material issues, Plant Operations to align material availability, inventory accuracy, and execution timing, Sales and Commercial leadership to support service commitments, escalations, and customer expectations
Own inventory accuracy and integrity, including establishing and maintaining cycle count programs, investigating and resolving inventory discrepancies, driving root cause and corrective actions to prevent recurrence, ensuring system and physical inventory alignment
Troubleshoot and resolve ERP/WMS material transaction issues, ensuring accurate and timely inventory movements across systems
Conduct regular inventory audits to ensure that all materials are accurately accounted for
Collaborate with purchasing teams to ensure that all materials are properly ordered and received

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Supervisor II, Distribution & Logistics

In this hands-on warehouse leadership role, you will be accountable for deliveri...

Location

United States , Charleston

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Strong technical knowledge of logistics and supply chain management, including operational and inventory management judgement, shipping and receiving, and quality control
Proven ability to lead small teams through presence and influence
Comfort operating hands-on on the floor while thinking at a senior level
Strong cross-functional communication and relationship building skills
Working knowledge of ERP/WPS systems (preferably SAP), inventory control, and cycle counting
Ability to operate effectively in a regulated, high-accountability environment
Proficiency in troubleshooting and repairing logistics equipment and systems
Excellent problem-solving and analytical skills
Strong attention to detail and ability to work independently or as part of a team
Bachelor’s Degree with 5+ years of progressive warehouse or operations leadership experience, including inventory control ownership OR High School Diploma/GED with 8+ years of progressive warehouse leadership experience, including senior-level accountability in a hands-on role

Job Responsibility

Review upcoming shipments aligned with customer requirements for orders not yet finalized or built and collaborate with Manufacturing and Planning to ensure product availability for timely shipment
Own end-to-end warehouse execution, including receiving, storage, picking, shipping, material handling, goods movement, transportation, and inventory control, with a strong hands-on presence on the floor
Lead and develop a small team of warehouse leads and associates, setting clear expectations, reinforcing accountability, and coaching for consistent performance
Drive performance against warehouse KPI’s including inventory accuracy, cycle count performance, service level, backorders, safety, and compliance
Actively work alongside the team as needed to remove barriers, resolve issues, and ensure critical priorities are met—especially during volume spikes, constraints, or high-risk execution windows
Build and sustain strong cross-functional partnerships with: Quality to ensure compliance, audit readiness, and timely resolution of inventory or material issues, Plant Operations to align material availability, inventory accuracy, and execution timing, Sales and Commercial leadership to support service commitments, escalations, and customer expectations
Own inventory accuracy and integrity, including establishing and maintaining cycle count programs, investigating and resolving inventory discrepancies, driving root cause and corrective actions to prevent recurrence, ensuring system and physical inventory alignment
Troubleshoot and resolve ERP/WMS material transaction issues, ensuring accurate and timely inventory movements across systems
Conduct regular inventory audits to ensure that all materials are accurately accounted for
Collaborate with purchasing teams to ensure that all materials are properly ordered and received

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Select Country

Senior Manager Manufacturing Programs - Investigations and Process Ownership

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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