Amgen

Project Manager - Chemistry Manufacturing Control (CMC)

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jul 28, 2021
Ref
R-118693
Required Education
High School or equivalent
Position Type
Contract

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Project Manager - Chemistry Manufacturing Control (CMC)

CMC integrates all of the process development activities into a unified project plan. This is another way of defining process development activities and is the phase of the project when a product has gone commercial where Amgen will have product variations (example: new SKU or variation, new manufacturing site, etc.)

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for coordinated Process Development (PD) activities by developing and maintaining technical project plans and schedules for late-stage and lifecycle projects which may include commercial PD activities, clinical manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices. Working with the Global Operations Leader and other members of the Product Delivery Team, the PM develops and aligns plans and schedules for PD activities with business priorities. The PM captures associated project risks, develops mitigation plans and communicates project status clearly to impacted partners. The PM assists with driving decision making for the project and ensures that action items are captured and supervised to completion. The PM partners with PD technical leads to identify key achievements and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. The PM ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. The PM assists PD technical leads with tracking the completion of required deliverables and assists with navigating project teams through corporate governance. You will have authoritative command with complexity and ambiguity, and is encouraged to have the ability to collect, digest and assemble information in order to enable relevant business analysis and influence decision-making.

Role Responsibilities:
  • Manage and prioritize support of multiple project teams at one time

  • Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication

  • Negotiate and resolve conflicts and drive decisions among team/functional members to accomplish project and business goals

  • Follow Amgens governance processes, procedures, specifications, and applicable compliance standards and guidance documents

  • Support projects that utilize internal and external personnel, contract firms, and partners

  • Use project controls to track project progress, keep the team informed and organized (e.g. project timeline, action items log, decision log, risk log, etc.)

  • 20% travel domestic and international

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The project manager professional we seek is a self-starter with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of Project Management, Operations or Process Development industry experience

OR

Bachelors degree and 5 years of Project Management, Operations or Process Development industry experience

OR

Associates degree and 10 years of Project Management, Operations or Process Development industry experience

OR

High school diploma / GED and 12 years of Project Management, Operations or Process Development industry experience

Preferred Qualifications
  • Minimum 3 years of project management experience in the Pharmaceutical, Biotechnology or direct CMC or PD PM experience

  • Deep understanding of Biologic and/or Synthetic Drug Substance/Drug Product development processes over the product life cycle, from pivotal to product launch including process characterization, product characterization and commercial tech transfer

  • Support any type of project, irrespective of phase or complexity

  • Experience with a manufacturing developmental partner (e.g. CMO)

  • Experience using Project Management Tools, methodologies, practices and infrastructure, as related to the Biopharmaceutical Industry; PMP Certification

  • Drug Substance/Drug Product development knowledge with basic to solid understanding of other functions relevant to the position which may include: Regulatory, Quality, Human Factors, Manufacturing, Packaging, Supply Chain, and Commercial

  • Ability to provide leadership in a highly fluid, interactive, matrix environment resulting in the advancement of sophisticated projects to completion

  • Ability to understand projects at the tactical level while maintaining the overall project strategy and priorities aligned

Thrive

Some of the vast rewards of working here

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

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

#Operations21

Equal Opportunity Statement

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


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.