Senior Project Manager - CMC Integration

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Full Remote
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Offer summary

Qualifications:

Doctorate degree with 2 years of Project Management experience, or a Master's degree with 6 years, or a Bachelor's degree with 8 years, or an Associate's degree with 10 years, or a high school diploma with 12 years of Project Management experience., Minimum of 10 years of experience in the Pharmaceutical, Biotechnology, or Healthcare field, with direct CMC experience preferred., Strong interpersonal and communication skills to interface effectively across all organizational levels., Proficiency in standard Project Management tools and practices, including MS Project, PowerPoint, Excel, MS Teams, and SharePoint..

Key responsibilities:

  • Develop and maintain project schedules for Client pipeline projects, focusing on Pivotal, Life Cycle Management, and Commercial programs.
  • Manage cross-functional teams within Process Development and ensure alignment with key deliverables.
  • Draft timeline scenarios to inform project execution and portfolio decisions, while facilitating communication in management reviews.
  • Track delivery of Process Development deliverables and report product metrics, incorporating lessons learned and best practices.

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Dale WorkForce Solutions SME https://daleworkforce.com/
11 - 50 Employees
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Job description

Client discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Client was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Client therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Client remains committed to advancing science to dramatically improve people's lives.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Client. For staff around the world, our mission to serve patients and our commitment to science makes Client a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.

Client is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. This role will be based on our main corporate campus in Thousand Oaks, CA. The Sr. Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing and maintaining project schedules for Client pipeline projects. This Sr. Project Manager will have the main focus on supporting programs in the Pivotal, Life Cycle Management and Commercial space working with the Operations Leader and the Product Delivery Team.

The Sr. PM will manage cross-functional teams within Process Development across all modalities (Biologics and Synthetics) as needed. They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans. They are expected to proactively manage plans to meet deliverables with their teams.
Partnering with key Product Delivery Team stakeholders, the Sr PM will need to understand the Clinical Development Plan and strategy to enable alignment with tox, clinical and commercial targets
The Sr PM will draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions
Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
Leverage soft skills, technical knowledge, and leadership attributes to influence positive project outcomes.
Assist PD in driving decision making and communication
Establish and manage collaboration and team sites. Track delivery and create repositories for all Process Development deliverables
Project reporting including appropriate risk analysis
Partner with Business Analysis and Performance to report product metrics
Facilitate and incorporate lessons learned, and best practices
Support Business Process improvements, including alignment with the Commercialization Office
Basic Qualifications:

Doctorate degree and 2 years of Project Management experience

OR

Master's degree and 6 years of Project Management experience

OR

Bachelor's degree and 8 years of Project Management experience

OR

Associate's degree and 10 years of Project Management experience

OR

High school diploma / GED and 12 years of Project Management experience

Preferred Qualifications:

Master's degree with 6 years of projects management experience, OR Bachelor's 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, PowerPoint, Excel, MA Teams and SharePoint highly desirable
Client 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.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration
  • Communication
  • Microsoft Excel
  • Microsoft PowerPoint
  • Critical Thinking
  • Virtual Teams
  • Social Skills
  • Problem Solving

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