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CMC Project Manager
Vancouver, WA, US
Scientific
Bachelors Degree
Full Time, Direct Hire
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Vancouver, WA, US
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Kelly® Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Workplace: Onsite in Vancouver, WA
Salary: $95,000-130,000
Overview
Drive CMC development, scale-up, cGMP manufacturing, and quality control for our AI-generated biologics. Manage CMC efforts at CDMOs, ensuring timely development of early-phase biologics. This role blends technical chemistry expertise, project management, and strong communication skills, with involvement in regulatory filings requiring technical writing and biologics regulations experience. Occasional travel required.
Responsibilities
Strategic Execution:
- Lead CMC activities at CDMOs for early-phase biologics.
- Provide technical guidance for cell line development, upstream/downstream processes, and more.
- Review and approve documents related to process development and characterization.
- Prepare program dashboards and presentations.
- Manage project budgets.
Project Management:
- Plan and track project timelines, ensuring cGMP compliance.
- Coordinate efficient and cost-effective project completion.
- Oversee commercial batch production.
- Keep senior management informed on program timelines and risks.
Cross-Functional Collaboration:
- Work closely with QA/QC on deviations, CAPA, and change control.
- Liaise with internal stakeholders and external partners.
- Lead work with partner organizations and consultants.
- Collaborate with CDMO for health authority inspections.
- Adhere to company policies, procedures, and safety rules.
Qualifications
- Bachelor’s degree in chemistry, chemical engineering, or pharmaceutical sciences; advanced degree preferred.
- Project management training desirable.
- Minimum 3 years in pharmaceutical development/manufacturing with a focus on CMC and biologics.
- Flexibility for non-traditional work hours due to international operations.
- Ability to prioritize, multi-task, and work in a high-pressure environment.
- Proficiency in MS Office, JMP statistical software, and Adobe Acrobat.
- Ability to travel up to 10%, including internationally.
Preferred
- Strong knowledge in cell line, upstream/downstream process development.
- Experience in formulation development and regulatory requirements.
- Proven track record in supporting CMC programs from development to commercialization.
- Experience in biotech, pharmaceutical, or healthcare industry.
What happens next:
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.