CMC Project Manager

2 weeks ago

Vancouver, United States Kelly Science, Engineering, Technology & Telecom Full time

Chemistry, Manufacturing & Controls (CMC) Manager


Kelly® Science & Clinical is seeking a Chemistry, Manufacturing & Controls (CMC) Manager for a direct hire position at a premier client 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.


Pay: $95-130k DOE


Overview

This client is an industry-leading biotech company focused on developing innovative therapies for rare genetic disorders. Our CMC Manager will drive the CMC development, scale up, cGMP manufacturing and quality control processes to advance internal pipeline of AI-generated assets. The CMC manager will coordinate the CMC efforts in CDMOs, driving timelines of early-phase biologics. This role requires a blend of technical expertise in chemistry and manufacturing processes, expertise in project management and strong internal and external communication skills. The CMC manager will also contribute to regulatory filings, requiring strong experience in technical writing and biologics regulations. Occasional travel is required.


Schedule: Monday-Friday

Hybrid


Responsibilities:

Strategic execution

  • Function as technical lead at contract development and manufacturing organizations (CDMOs) for early phase biologics drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.
  • Provide technical guidance for cell line development, upstream process development, downstream process development, formulation development, analytical development, and drug product development.
  • Review and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.
  • Preparation of program/platform dashboards and presentations.
  • Manage project budgets to target.

Project Management

  • Responsible for assigned project/timeline planning and tracking of commitments, communication of commitments to team members.
  • Keep projects in compliance with cGMP regulations.
  • Coordinate activities to ensure efficient and cost-effective project completion.
  • Coordinate production of commercial batches as needed.
  • Ensure that senior management/development teams are informed of important program timelines, milestones and risks.

Cross-Functional Collaboration

  • Work closely with QA/QC to identify and evaluate deviations, CAPA and change control.
  • Serve as a liaison between internal stakeholders and external partners, such as contract development and manufacturing organizations (CDMOs) and vendors.
  • Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.
  • Collaborate with CDMO for health authority inspection.
  • Adhere to all company policies, procedures and safety rules.


Qualifications:


  • Bachelor’s degree in a technical field such as chemistry, chemical engineering or pharmaceutical sciences. Advanced degree preferred. Specific project management training is desirable.
  • Minimum 3 years of industry experience in pharmaceutical development and manufacturing, with a focus on CMC; required knowledge of biologics development process; experience interacting with key functional stakeholders such as manufacturing, QA, QC, and supply chain.
  • Flexibility to work non-traditional work hours when needed, given international operations across time zones.
  • Experience working with antibodies
  • Proven experience of ability to prioritize, multi-task, and work in an evolving and high-pressure environment.
  • Proficiency in MS Office [Excel, Word, PowerPoint, MS Project], JMP statistical software (desired) and Adobe Acrobat.
  • Ability to create and deliver presentations to influence and inform individuals across functions and levels within the organization.
  • Ability to travel up to 10% of the time. This will include outside of the United States.


Preferred (but not required):

  • Strong knowledge in cell line development, upstream and downstream process developments.
  • Experience in formulation development is desired.
  • Strong understanding of the regulation requirements from FDA and other regulatory agencies.
  • Proven track record of successfully supporting CMC programs from development through commercialization.
  • Demonstrated ability to manage multiple projects simultaneously and prioritize effectively in a fast-paced environment.
  • Experience in the biotech, pharmaceutical, or healthcare industry.



What happens next:


Once you apply, you’ll proceed to 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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