Sr. Project Manager - CMC Integration

Overview

Hybrid
Depends on Experience
Full Time

Skills

Biotechnology
Process Engineering
Project Management
CMC
Chemistry
Manufacturing
Chemistry Manufacturing and Controls
Controls
R&D
Research & Development

Job Details

Job Description:

AgreeYa is a global Systems Integrator and is seeking an experienced a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. The Sr. Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing and maintaining project schedules for 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.

Ideal Candidate: Looking for 7-10 years of experience including a strong technical pharma/bio tech background.

Nice to have: drug substance or drug product, and device expertise

Nice to have tools: Planisware, MS Project, Smartsheet

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 5-7 years of Project Management experience

OR

Bachelor s degree and 7-10+ 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

About AgreeYa:

AgreeYa is a global systems integrator delivering a competitive advantage for its customers through software, solutions, and services. Established in 1999, AgreeYa is headquartered in Folsom, California, with a global footprint and a team of more than 1,800+ professionals across offices. AgreeYa works with 550+ organizations ranging from Fortune 100 firms to small and large businesses across industries such as Telecom, Banking, Financial Services & Insurance, Healthcare, Utility & Energy, Technology, Public Sector, Pharma & Biotech, Retail, Client, and others. Please visit us at for more information.

Equal Opportunity:

AgreeYa is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender identity, sexual orientation, national origin, disability, veteran status or other protected characteristics. Visit our website at to learn about our Career & Culture.

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