Project Manager CMC
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Project Manager to work for a leading San Diego biotechnology company.
Project Manager CMC
- Reporting to the Head of Process Development to Partner with Scientific Lead for multiple complex development projects in Asia to achieve product development and manufacturing goals
- Develop and maintain integrated CMC project plans to identify/communicate interdependencies as well as critical path activities across multiple development programs.
- Facilitate CMC team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of CMC objectives
- Work collaboratively with CMC functions (Process Development, Supply Chain, Analytical Development, Quality Control, Quality Assurance, and Regulatory) to ensure strong, clear communication to identify and address challenging issues in product development and manufacturing
- Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various CMC projects, as well as ensure CMC teams are aware of current integrated program timelines
- MS or PhD in the life sciences
- 8+ years of relevant biopharmaceutical industry experience. Previous late phase (Phase 2/3 to Post Launch) experience in analytical development, process development, and manufacturing of biologics/cell & gene therapy a plus.
- 3+ years of Project Management at a fast-paced, innovative biotech/pharma company. Commercial project management experience preferred. Mandarin speaking a plus.
- 2+ years as a Lean Six Sigma Black Belt with Organizational Change Management (OCM) experience in a fast-paced, innovative drug development environment.
- Track record of successfully driving, managing and implementing Lean Six Sigma projects such that they integrate effectively with the overall objectives of the functions and/or corporation they support.
- Expert knowledge and proficiency of MS Project, MS Visio, and the Microsoft Office Suite
- Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Proven ability to distill complex plans across multiple programs into an intuitive, simple and clear communication to facilitate prioritization and resourcing
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and great problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent communication skills and ability to influence across multiple functions.