CDMO Project Manager at Azzur Group in San Francisco, California

Job Description:

Equal Employment Opportunity/M/F/disability/protected veteran status


Azzur Group

Azzur Group San Francisco is looking for mid to senior level CDMO Project Managers specializing in biologics manufacturing to join our dynamic team. As a pivotal member of our organization, you will be responsible for overseeing the seamless execution of biologics manufacturing projects at our client’s contracted sites. This role demands a deep understanding of biopharmaceutical processes, project management expertise, and the ability to collaborate effectively across multidisciplinary teams.

Essential Duties and Responsibilities

• Project Planning and Execution:
  • Lead the planning, initiation, execution, monitoring, and closure of biologics manufacturing projects at CDMO facilities.
  • Develop comprehensive project plans, timelines, and milestones, ensuring alignment with client requirements and regulatory guidelines.
  • Proactively identify potential risks and develop mitigation strategies to ensure project success.
• Client Communication and Relationship Management:
  • Serve as the primary point of contact for clients regarding project progress, timelines, and deliverables.
  • Foster strong client relationships through regular communication, addressing inquiries, and providing updates on project status and deviations.
• Team Coordination and Leadership:
  • Collaborate with cross-functional teams including process development, quality assurance, regulatory affairs, and supply chain to ensure project objectives are met.
  • Provide leadership and direction to project team members, fostering a culture of accountability, collaboration, and continuous improvement.
• Quality and Compliance:
  • Ensure adherence to cGMP and regulatory requirements throughout the project lifecycle.
  • Conduct regular quality assessments and audits to maintain compliance and address any deviations promptly.
• Financial Management:
  • Manage project budgets, forecasting expenditures, and ensuring cost-effective utilization of resources.
  • Monitor financial performance against agreed-upon metrics and take corrective actions as necessary.
• Continuous Improvement:
  • Identify opportunities for process optimization and efficiency gains within biologics manufacturing operations.
  • Implement best practices and lessons learned from previous projects to drive continuous improvement initiatives.

Required Experience

• Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Biochemistry, Biotechnology) required; advanced degree (MSc or PhD) preferred.
• Proven experience (8+ years) in project management within the biopharmaceutical industry, specifically in biologics manufacturing.
• In-depth knowledge of biologics production processes, including upstream and downstream operations.
• Strong understanding of cGMP guidelines, FDA regulations, and other relevant regulatory requirements.
• Excellent communication skills with the ability to interact effectively with clients, stakeholders, and team members.
• PMP certification or equivalent project management credentials preferred.
• Demonstrated leadership abilities, with a track record of successfully managing complex projects from initiation to completion.
• Proficient in Microsoft Word, Excel, Power Point, Project and able to quickly learn new computer applications.

Key Attributes:

• Strategic thinker with the ability to prioritize tasks and manage multiple projects simultaneously.
• Detail-oriented with a focus on quality and compliance.
• Strong problem-solving skills and the ability to make informed decisions under pressure.
• Team player who thrives in a collaborative environment and can motivate others towards common goals.
• Adaptability and resilience in the face of challenges and changing project scopes.

Location: This position is mostly remote, with occasional travel required to CDMO sites and client meetings as needed.

Azzur Core Values:

Puts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!

#LR-KR1

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.

PI243084232

Apply Now