Senior Project Manager - CMC Integration Project Management

Initial Therapeutics, Inc.

Thousand Oaks (CA)

Hybrid

USD 130,000 - 190,000

Full time

6 days ago
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Benefits offered by this job

Retirement plan
Annual bonus program
Stock-based incentives
Flexible work model

Job summary

Amgen is seeking a Senior Project Manager in CMC Integration to drive cross-functional program delivery across Process Development. You will coordinate timelines for Pre-Pivotal, Pivotal, and Lifecycle stages, partnering with technical leads to ensure alignment with clinical and commercial goals.

You will manage PD teams, support governance reviews, and push for decisions that keep programs on track, while applying lessons learned to improve processes and outcomes across projects.

Qualifications

  • Requires doctorate with 2+ years PM experience or advanced degrees with commensurate PM experience.
  • Experience leading cross-functional teams in Process Development or related PD functions.
  • Ability to build and maintain project timelines for Pre-Pivotal, Pivotal and Lifecycle stages.
  • Strong communication to support governance reviews and risk reporting.

Responsibilities

  • Partner with Process Development leaders to build timelines aligned with clinical and commercial targets.
  • Ensure active, aligned communication in governance meetings.
  • Drive effective decision making and clear reporting.
  • Establish and manage collaboration sites; track delivery and repositories for PD deliverables.
  • Report product metrics with Business Analysis and Performance teams.
  • Incorporate lessons learned and best practices across projects.
  • Support Business Process improvements including the Commercialization Office alignment.
  • Provide risk analysis and project reporting.
  • Lead and coach a team of PMs across products and projects.

Skills

Cross-functional collaboration
Interpersonal communication
Critical thinking
Project coordination

Education

Doctorate
Masters
Bachelor's
Associates
High school diploma / GED

Tools

MS Project
Excel
SharePoint

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Project Manager - CMC Integration Project Management
What you will do

In this vital role you will be responsible for integrating and understanding Process Development activities by developing and maintaining project timeline for Pre-Pivotal, Pivotal and Lifecycle Management projects within Amgens commercial portfolio.

The Sr. PM will manage cross-functional teams within Process Development across all modalities as needed. They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans. They are encouraged to proactively manage plans to meet deliverables with their teams.

  • Partner with Process Development leaders as a part of the Product Delivery Team to build project timelines that align with and support, clinical and commercial targets.
  • Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
  • Assist PD in driving decision making and communication
  • Establish and manage collaboration and team sites. Track delivery and build repositories for all PD deliverables
  • Partner with Business Analysis and Performance to report product metrics
  • Facilitate and incorporate lessons learned, best practices, etc
  • Support Business Process improvements, including alignment with the Commercialization Office
  • Project reporting including appropriate risk analysis
  • Managing/coaching a team of project managers supporting various products and projects
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process Development Project Manager professional we seek is a collaborative team player with these qualifications.

Basic Qualifications:
  • Doctorate degree and 2 years of Project Management experience OR
  • Masters degree and 4 years of Project Management experience OR
  • Bachelors degree and 6 years of Project Management experience OR
  • Associates degree and 10 years of Project Management experience OR
  • High school diploma / GED and 12 years of Project Management experience
Preferred Qualifications:
  • Masters degree with 6 years of projects management experience, OR Bachelors degree with 8 years of project management experience.
  • Minimum of 10 years of experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable
  • Ability to foster collaboration and work effectively on cross-functional teams
  • Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization
  • Critical thinking and problem solving skills
  • Apply standard Project Management tools, and practices; experience with MS Project, Excel and SharePoint highly desirable
What you can expect of 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, well support your journey every step of the way.

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 & vision coverage, and life & disability insurance
  • 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
  • Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Sponsorship

Sponsorship for this role is not guaranteed.

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.

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.

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