Total 4 manufacturing production job vacancies in san francisco california

Career Category

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.

Contracts and Development Manufacturing Manager

Live

What you will do

Let’s do this! Let’s change the world!

Amgen is seeking a Manager to join the Amgen Contract Development and Manufacturing (ACDM) Organization. The location can be based out of either Thousand Oaks, CA or Cambridge, MA office and may exist in a virtual setting. The ACDM Manager will oversee contract test labs to deliver on Amgen’s pipeline and commercial products. The ACDM Manager will be responsible to ensure multiple Amgen programs meet critical timelines at external partner analytical and manufacturing sites.

Job Responsibilities include:

• Project leadership for analytical testing of pipeline and commercial drug product and drug substance programs. Primary focus will be to manage delivery of analytical work packages (method validation, method transfer, release testing, stability testing) on time to support pipeline and commercial programs.

• Supplier relationship management, including reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers.

• Ensuring programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.

• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects.

• External vendor evaluation and selection.

• Self-starter who can manage multiple assignments.

• Building and maintaining strong partnerships with internal and external functions to increase overall effectiveness and success of programs.

• Ability to lead highly matrixed teams.

• Presentation of analyses and recommendations to Senior Management.

• This position will require occasional domestic and international travel.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The management professional we seek is a collaborative cross-functional leader with these qualifications.

Basic Qualifications

• Doctorate degree OR

• Master’s degree and 2 years of experience OR

• Bachelor’s degree and 4 years of experience OR

• Associate’s degree and 8 years of experience OR

• High school diploma / GED and 10 years of experience

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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

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.

Associate Manufacturing

Live

What you will do

Let’s do this! Let’s change the world! In this dynamic role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility. Responsibilities of the role include:

• Executing drug product filling and formulation activities, respectively

• Performing initial review of manufacturing batch records

• Maintaining a safe and compliant culture by identifying preventative measures

• Creating and/or revising standard operating procedures

• Leading continuous improvement initiatives, which may be cross-functional in nature

• Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams

• Developing finite schedule for tasks including, but not limited to unit operations

• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence

• Elevating critical and impactful events to management

• Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)

• Supporting the introduction of new products and technologies into the facility

• Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Bachelor’s degree OR Associate’s degree and 6 months of Manufacturing experience OR High school diploma / GED and 2 years of Manufacturing experience

Preferred Qualifications:

• B.S. in a life science or related field

• 2 years of work experience in a GMP environment

• Ability to perform computer operations, such as ability to navigate in MS Office and Excel

• Ability to operate specialized equipment and computers as appropriate to the individual area

• Ability to adhere to regulatory requirements, written procedures and safety guidelines

• Ability to evaluate documentation/data according to company and regulatory guidelines

• Ability to interact with inspectors (internal and external)

• Technical writing capabilities

• Ability to organize work, handle multiple priorities and meet deadlines

• Demonstrated written and oral communication skills

• Presentation capabilities

• Detail oriented as well as flexible and adaptable to changing priorities and requirements.

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.

Amgen offers a Total Rewards Plan comprising health 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

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.

Senior Manufacturing Systems Engineer (Automation)

Live

What you will do

Let’s do this. Let’s change the world. As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support B7 EPO Commercial Drug Substance plant operations This includes complex and challenging system automation initiatives that require understanding of various automation platforms, integration between multiple platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.

Responsibilities include:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), ABB robotics, and Mitsubishi roller bottle machine.
• Lead/support technical root cause analysis, incident investigations, and trouble shooting on process control issues related to plant operations.
• Own change control records, CAPA records and deviations as it relates to Automation systems.
• Support functional area projects focused on improving process equipment, cleaning systems and utilities to ensure reliability of drug substance manufacturing facility.
• Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s Ambitious goals.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Support Review by Exception (RbE) functionality for all EPO systems that includes product Batch records, cleaning, and sterilization systems, Audit trail and version control systems.
• Collaborate with Amgen Drug Substance Plant network to enhance the automation design for EPO Drug Substance Plant Operations
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Day-to-day Operational Support including:
• Direct Manufacturing Support required for Critical Operations
• 24 x 7 Onsite/On Call as required.
• Trouble shooting Support to Manufacturing operations, cleaning systems, plant utilities and Building management system
• Automation System Administration
• Automation System Operating Systems (OS) security patching and HotFix assessments and rollout
• Daily manufacturing and engineering work center team meetings
• Preventative and corrective maintenance
• Automation System spare parts management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Automation professional We seek has these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of Manufacturing Automation Engineering experience

Or

Bachelor’s degree and 5 years of Manufacturing Automation Engineering experience

Or

Associate degree and 10 years of Manufacturing Automation Engineering experience

Or

High school diploma / GED and 12 years of Manufacturing Automation Engineering experience

Preferred Qualifications:

• Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
• Demonstrated hands-on experience in developing process control strategies in Clinical/Commercial Drug Substance Plant Operations.
• Familiarity with Upstream and Downstream unit operations.
• Direct knowledge of Automation design, experience in process control engineering and trouble shooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, and ultrafiltration/diafiltration, roller bottle processing, and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times; reduced plant utilities usage) related to Drug Substance Plant Operations.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope, and cost estimate development, case development, detailed design, engineering and validation documentation and project execution are a plus.
• The ideal individual must be a self-directed standout colleague ready to mentor. engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
• Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
• 3+ years’ combined experience with the following:
• Emerson Delta-V DCS system
• Rockwell Automation SCADA and PLC Platform.
• ABB Robotics
• Mitsubishi Programmable Logic Controllers
• Electronic Batch Reporting Systems Design and implementation experience.
• Process Control Network design including network segregation.
• Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced trouble shooting activities in coordination with Amgen IS.
• System Integration using OPC, Profibus, Serial VIM, Ethernet and DeviceNet technologies.
• Compliance and regulatory requirements such as 21 CFR Part 11, S88, S95 and GAMP.

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.

Amgen offers a Total Rewards Plan comprising health 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Principal Manufacturing Systems Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will develop a matrixed team of engineers to implement strategic development of automation technologies for Amgen. The team will design, develop, and deliver innovative solutions enabling the advancement and intensification of Amgen processes.

Responsibilities include:

• Manage and lead process automation support teams for MCS Drug Substance manufacturing in Thousand Oaks, CA.
• Network internally and externally to define problem statements and identify key technologies and potential solutions in the advanced automation and process control field.
• Plan and implement change efforts for automation strategy for the company, beginning in the Manufacturing and Clinical Supply (MCS) organization.
• Define the strategy for automation and process control within MCS Drug substance manufacturing. Partner with senior management within Process Development to secure resources for programs of critical importance.
• Lead the team implementing the development strategy. As part of the Facilities & Engineering (F&E) group within the Manufacturing Clinical Supply (MCS) organization, the Principal Manufacturing Systems Engineering will work with the Senior Manager Engineering Manufacturing Systems at Amgen.

This role is expected to provide leadership as follows:

• Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.
• Partner with Process Development, Amgen IS, and commercial manufacturing teams to ensure compliant delivery of developed solutions.
• Strategic and tactical management and leadership in providing day to day operational support and capital project support, mentoring, staff development, team productivity, and efficient use of available resources.
• Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives execution.
• Providing input into department objectives and establishing strategic direction within the Drug Substance Network F&E automation team.
• Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership and other technical staff in the network, focusing on “predict and prevent” systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment Maintenance.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
• Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure the safety of all personnel during plant operations and engineering activities.
• Ensure that all staff are adequately trained and follow all GMP standards and procedures.
• Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.
• Develop and adhere to department budgets and spend for operational and capital expenses.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

Or

Master’s degree and 6 years of Engineering experience

Or

Bachelor’s degree and 8 years of Engineering experience

Or

Associate’s degree and 10 years of Engineering experience

Or

High school diploma / GED and 12 years of Engineering experience.

Preferred Qualifications:

• Masters and/or Ph. D. in Chemical Engineering, Electrical Engineering, or related field.
• 10-15 years experience working in the process automation field within the biopharmaceutical industry.
• Ability to work independently and in small or large groups.
• Demonstrated proficiency in implementation of advanced process control applications in an industrial setting (e.g. Model Predictive Control, Adaptive Control).
• 5-10 years experience as an engineer or system administrator within the DeltaV Distributed Control System, Rockwell, ABB Robot, Mitsubishi Roller Bottle machine, Plant utilities, cleaning system and Building management system.
• Greater than 4 years proven experience leading matrixed teams.

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.

Amgen offers a Total Rewards Plan comprising health 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range