11 days old

GMP Project Manager (Biotech/CDMO), Irvine area, CA

Kelly Services
Tustin, CA 92781
**GMP Project Manager (Biotech/CDMO), Irvine area, CA**

**Position Summary:** Support the project management office (PMO) effort for the projects as assigned by planning and coordinating cross-functional activities of designated project(s) to ensure that goals or objectives of project(s) are accomplished within prescribed time frame and funding parameters. Functional involvement includes but is not limited to facilitating activities related to operations, regulatory, clinical, pre-clinical, and Chemistry/Manufacturing/Controls.

**Essential Duties and Responsibilities:**

+ Supports the PMO implementation of standardized templates, project governance, project process flow, and resource allocation tools and techniques.

+ Supports the planning/preparation/facilitation of extended meetings (pre-BLA, commercialization plan review, etc.).

+ Supports project readiness activities related to process validation and commercialization (documentation, schedule, resources, risk assessment, budgeting, and ability to function as a member of PIP team during engineering and process validation runs).

+ Supports project interface with operations/outside contractor/supply chain for commercial production readiness, schedule and facilitate sub-team (as assigned) meetings.

+ Provides Project Management support to all assigned projects including oversight of project charter, project plan/timeline, risk management and risk elevation.

+ Responsible for effective meeting facilitation, maintenance of meeting minutes, and action item generation, follow-up, and elevation for all assigned projects.

**Job Requirements:**

+ **B.S. / M.S. in a scientific discipline with 5 years of biotechnology or pharmaceutical experience in a project management role.**

+ Project Management certification is desirable.

+ Proficiency in MS Project is required.

+ Attention to detail, ability to multi-task, familiarity with the drug development process, and strong written and oral communication skills are required.

+ **Travel:** Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings.

**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:**

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-11-20 Expires: 2020-12-21

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GMP Project Manager (Biotech/CDMO), Irvine area, CA

Kelly Services
Tustin, CA 92781

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