Sr Associate Project Manager - Remote

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models (remote & hybrid)

Retirement and Savings Plan

Medical/dental/vision coverage

Stock-based long-term incentives

Job summary

Amgen Inc. (IR) is seeking a Sr Associate Project Manager in the Biosimilars PD/Operations group in the U.S. The role manages analytical similarity sample workflows, coordinating data and documentation through regulatory submission and cross-functional collaboration.

You will work with a diverse team to ensure accurate data verification and compliant ELN/LIMS processes. The position emphasizes strong organizational skills, experience in biotech/pharma settings, and the ability to manage multiple

Qualifications

• Master’s degree or Bachelor’s degree with 2 years of Project Management experience
• Associate’s degree with 6 years of Project Management experience
• High school diploma / GED with 8 years of Project Management experience
• Experience supporting pharmaceutical R&D or biotech industry
• Experience coordinating regulatory documents throughout the document lifecycle
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment

Responsibilities

• Provide project management to technical teams developing biosimilar candidates through to regulatory approval
• Provide project management of biosimilar business unit analytical similarity sample management
• Collaborate with cross-functional teams to plan and maintain inventory
• Manage logistics for distribution of samples for testing and communicate data
• Create electronic laboratory notebooks (ELN) for sample submission
• Generate lot numbers, sample IDs, and retrieve data in LIMS and ELN
• Assist staff with ELN software navigation and work orders
• Conduct data verification and organize data for regulatory filings
• Archive documents in controlled repositories and ensure compliance with guidelines

Skills

Project management

Biotech/pharma knowledge

Cross-functional collaboration

Regulatory documentation

Data management systems

MS Word

MS Excel

Education

Master’s degree

Bachelor’s degree in life sciences

Associate degree

Tools

ELN software

LIMS

Document management systems

Job description

Career Category Project Management Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate Project Manager Live

What you will do

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

The Project Manager will work in the Biosimilars Business Unit PD/Operation group, responsible for analytical similarity sample management of biosimilar programs to commercialization.

Manages/optimizes routine workflows to support technical teams responsible for developing biosimilar candidates through to regulatory approval.

Regularly interacts with management and cross-functional contacts.

Skills: strong analytical skills; strong MS Word and MS Excel skills; knowledge of good data practices/data verification, understanding of systems for sharing and collaboration; excellent communication skills.

• Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval
• Provide project management of biosimilar business unit (BBU) analytical similarity sample management.
• Collaborate closely with cross-functional team including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory.
• Manage logistics for distribution of samples for testing and communicate incoming data for biosimilar projects.
• Create electronic laboratory notebooks (ELN) for sample submission.
• Generate lot number, sample ID, and retrieving data in QC LIMS.
• Assist BBU staff with navigating ELN software and placing work orders for ELN updates.
• Database queries of LIMS, ELN and other databases including the compiling and organizing data to review, verify independently or in coordination with Data Management.
• Retrieve and organize data for review with Data Management
• Document archival in controlled document repository
• Provide data verification as needed for internal documents and regulatory filings in controlled document system.
• Utilize a strong foundation in scientific principles to thoroughly review regulatory documents and accurately determine the data elements that require verification in accordance with established protocols.
• Collaborate with cross-functional teams to ensure the completion and accuracy of the data verification processes.
• Assist in formatting documents in compliance with Amgen's internal style guidelines and standards.

Win What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

The Sr Associate Project Manager we seek is a motivated professional with these qualifications.

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of Project Management experience
• Associate’s degree and 6 years of Project Management experience
• High school diploma / GED and 8 years of Project Management experience

Preferred Qualifications

• Experience supporting pharmaceutical research and development or nonclinical drug development programs within the biotechnology, pharmaceutical, or life sciences industry.
• Experience working with document management systems, collaboration platforms, and project management tools.
• Experience coordinating scientific or regulatory documents throughout the document lifecycle.
• Strong organizational skills with the ability to manage multiple priorities in a dynamic, fast-paced environment.
• Bachelor's or advanced degree in a life science discipline, regulatory affairs, business, or a related field.

Thrive What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, 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 and hybrid work arrangements, where possible

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen anticipates accepting applications until 9/11; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.

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.

Salary Range 89,168.40USD -120,639.60 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen