Total 9 job vacancies by 1001 Amgen Inc.

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Quality Assurance Specialist - PQA

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsibilities include the following:

• Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a well-rounded team player with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in Life Science or Engineering.
• Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
• Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian).
• Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
• Strong organizational skills, including ability to follow assignments through to completion.
• Excellent written and verbal communication skills.

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 Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

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 Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

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?

Do more with the knowledge you’re working hard to acquire and the passion you already have. 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. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Global Quality Compliance Undergrad Intern

Live

This could be your everyday

Let’s do this. Let’s change the world. During this program, you will be working closely with the quality compliance team to help prepare to prepare the global auditing processes for migration into a new electronic system. You will have the opportunity to immerse yourself in learning drug/combination product/medical device auditing regulations while helping to streamline and simplify processes.

• Assist in Gathering User Requirements
• Help to Develop Workflows
• Redline and Process Procedural Updates
• Establish Standardized Forms, Reports
• Help to Plan and Execute Workshops

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The quality minded individual we seek is detail orientated with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship

Preferred Qualifications

• Degree concentration(s) in life sciences or engineering.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-170795

#NBMBAA

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.

Material Compliance Associate

Live

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Material Compliance Associate at our Thousand Oaks, CA, campus. In this vital role, you will be responsible for assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review and approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process.

• Quality check submissions for review to ensure alignment with internal standards

• Work with agencies and internal staff, including training on next steps and advising on process standards

• Provide administrative support during review meetings, including gathering “live” edits on submission documents

• Assist with Label updates

• Periodically assist on a variety of MAC-related projects

• Run Veeva reports and communicate outputs to cross-functional partners

• Proofreading commercial and training materials produced by the Marketing teams

• Revise documents electronically

Other skills

• Actively listen to and capture comments from meeting stakeholders

• Anticipate edits and work proactively to suggest solutions

• Ability to champion collaboration, work effectively on cross-functional teams, and consistently deliver timely

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills

• Critical thinking and problem-solving skills

• Quick learner, proactive, takes initiative

• Able to distinguish an accurate balance between strategic and tactical thinking

• Strong experience with Project Management tools, methodologies, and practices

• Proven ability to manage in a highly fluid, interactive, matrix environment

• Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats

• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest, and assemble information to enable relevant business analysis and influence decision-making

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Bachelor’s degree

Or

• Associates degree and 4 years of Marketing Communications Project Management / Copy-Editing experience

Or

• High school diploma, or GED, and 6 years of Marketing Communications Project Management / Copy-Editing experience

Preferred Qualifications:

• Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field or other regulated industries

• Experience in leading the creation of marketing materials from concept to commercialization

• Experience managing the approval process of marketing materials that are produced at high volumes.

• Copy-Editing experience including excellent typing and spelling skills

• Able to proofread materials using Adobe Acrobat Professional

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.

SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ PRECISION MEDICINE QUALITY

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will report to the Senior Director, In-Vitro Diagnostics (IVD) and Precision Medicine Quality. The Senior Manager, In-Vitro Diagnostics/ Precision Medicine Quality supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.

The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.

Responsibilities

• Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure. Contributes to the use of innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs.

• Collaborate with colleagues in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations.

• Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the European Union.

• Leverages metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.

• Collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution, and support of regulatory filings.

• Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.

• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).

• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of quality management experience OR

Master’s degree and 6 years of quality management experience OR

Bachelor’s degree and 8 years of quality management experience OR

Associate’s degree and 10 years of quality management experience OR

High school diploma / GED and 12 years of quality management experience

Preferred Qualifications:

• At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.

• An understanding of medical device development and applicable Global Regulations.

• An understanding of Precision Medicine and applicable Global Regulations.

• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).

• Experience preferred working within research and development of In-vitro Diagnostics.

• Implementation of technology to improve knowledge management across a diverse R&D environment.

• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

• Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.

• Innovative thinking, including the application of quality by design principles

• Collaborative worker with an ability to support a high performing team.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

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.

Manager Quality, Operations (3rd Shift)

Live

What you will do

Let’s do this! Let’s change the world! In this role you will be managing the Plant Quality Assurance (PQA) team, responsible to lead all aspects of the assembly and packaging operations. A key aspect of this role is to ensure quality and compliance to GMP regulations for all assembly and packaging operations.

The Manager PQA will play a key role in the Quality Assurance team, focused on building a strong PQA team and establishing efficient Plant Quality processes. The PQA team leads all aspects of quality of manufacturing operations (assembly and packaging) and is responsible for batch disposition of the produced Finished Drug Product at the site. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing. The team assures the Finished Drug Product is dispositioned in a timely manner to supply every patient every time.

You will support all activities for the set-up of the new assembly and packaging area, working closely with manufacturing to define production processes using a risk-based approach. You will build and own an impactful PQA team supporting manufacturing in a shift structure that may include second, third and/or weekend as a normal schedule.

• Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Finished Drug Product is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks.
• Responsible for selection, training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities.
• Provide oversight of the QMS process implementation applied in manufacturing, including deviation management, CAPAs, work-orders and change controls.
• Interact with Manufacturing, Process Development and other partners for raised cases of deviations related to process, equipment or materials.
• Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Own and review related SOPs, methods, protocols and reports. Provide training and oversight for staff.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Drive Lean Transformation and Operational Excellence initiatives.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Educational background in life sciences or equivalent
• Strong in managerial skills, coaching, mentoring and counseling
• Experience in a GMP controlled environment
• Familiarity with equipment commissioning and qualification activities
• Affinity with digital innovation and data sciences
• Excellent written and verbal communication, ability to work in a team matrix environment and build relationships with partners
• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
• Strong organizational skills, including ability to follow assignments through to completion

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.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

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?

Do more with the knowledge you’re working hard to acquire and the passion you already have. 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. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Undergrad Intern - Global Supply Quality - Contract Manufacturing Quality

Live

This could be your everyday

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

Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Utilizing external contracted manufacturing services is a key strategy to ensure the delivery of Amgen products to our patients. Global Supply Quality’s (GSQ) objective is to ensure the quality of the materials and products we receive from our external suppliers and contract manufacturers. The North America arm of Global Supply Quality is seeking a highly motivated, hardworking undergraduate to fulfill a 2024 summer internship role under supervision of the Director of the organization. This internship will be approximately 12 weeks and includes both project-based and experiential learning. This position is to be fulfilled in a remote work setting, with the possibility of travel to internship events at one of our locations. The intern will be an integral member of the North America Global Supply Quality organization and will be focused on applying innovation and data driven strategies to simplify processes. The areas to be supported include: Portfolio Management, Business Operations, and Continuous Improvement. As a member of Amgen's GSQ Organization, your work will be highly collaborative across multiple functions and levels within Amgen, including, for example: Quality, External Supply, Supply Chain, Engineering, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance GSQ’s mission, including the following:

• Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables
• Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects
• Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management
• You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen’s Employee Resource Groups

This job description serves as a general outline for the responsibilities of an undergraduate intern in GSQ. The specific tasks and requirements may vary depending on the organization and its projects.

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The individual we seek should be self-motivated and display the following qualifications:

Basic Qualifications

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship OR co-op

Preferred Qualifications

• Majoring in Engineering or a Biotech related STEM discipline
• Interest in Project Management and Finance
• Strong communication, interpersonal, organizational, project management, and problem-solving skills
•  Strong analytical and quantitative skills
• Demonstrated personal initiative, self-motivation, flexibility and adaptability

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-179444

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 a 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 an accommodation.

Salary Range