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14 days old

CMC Project Manager

Kelly Services
San Diego, CA 92108
**Title: CMC Project Manager**


**Location: San Diego, CA**


**Work Type: Full-Time, Direct-Hire, Hybrid (will need to be local to San Diego or willing to relocate)**


**Responsibilities:**

1. Lead China-USA/EU technology transfer projects including identification/selection of CDMOs, contract negotiation and project management of tech-transfer activities and GMP manufacturing at CDMOs.

2. Lead global program CMC activities by working effectively and collaboratively with stakeholders (Regulatory Affairs, Manufacturing, QA, QC, Supply Chain & Sourcing, Process Development, Analytical Development, R&D) at the different stages of development.

3. Develop and maintain integrated CMC project plans to identify/communicate interdependencies as well as critical path activities.

4. Drive cross-functional communication and effective decision making, utilizing

meeting management best practices. Prepare and present CMC project status reports and metrics to cross-functional Teams and Management.

5. Facilitate relevant CMC scenario planning particularly around key program inflexion points, gathering stakeholder inputs, evaluating options and determining the teams recommendations.

6. Ensure proactively identifying risks and issues and driving to the right resolutions and contingency plans by cross functional teams.

7. Provide inputs on regulatory strategies, author product-specific questions and CMC content as appropriate and review of product-related regulatory submissions.


**Requirements:**

1. M.S. in a scientific or technical field; Advanced Science degree preferred

2. **Minimum of 8 years of total** relevant experience for Gene/Cell therapy (including industry CMC, project management, or academia).

3. Demonstrated Project Management experience in the technical/CMC environment for biopharmaceutical programs preferred

4. Demonstrated matrix team leadership capability with excellent project management skills

5. Proven ability to communicate (written and verbal) clearly and objectively to provide appropriate context, articulate views, drive clarity, and address barriers to progress program CMC development

6. Strong facilitation and collaborative skills

7. PMP certification preferred


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Jessica at jessica.rubano@kellyscientific.com_**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-13 Expires: 2022-06-13

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CMC Project Manager

Kelly Services
San Diego, CA 92108

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