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Company

Original Job Post

Azzur Group · 2 days ago

CDMO Project Manager

San Francisco, CA

Full-time

Hybrid

Mid, Senior Level

8+ years exp

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BiotechnologyConsulting

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Responsibilities

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.

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.

Collaborate with cross-functional teams including process development, quality assurance, regulatory affairs, and supply chain to ensure project objectives are met.

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.

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.

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.

Qualification

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Project managementBiopharmaceutical industryBiologics manufacturingCGMP guidelinesFDA regulationsRegulatory requirementsMicrosoft WordExcelPowerPointComputer applicationsCommunicationLeadership

Required

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.

Demonstrated leadership abilities, with a track record of successfully managing complex projects from initiation to completion.

Proficient in Microsoft Word, Excel, PowerPoint, Project, and able to quickly learn new computer applications.

Preferred

PMP certification or equivalent project management credentials preferred.

Company

Azzur Group

From Discovery to Delivery®, Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs.

Founded in 2010

Willow Grove, Pennsylvania, USA

201-500 employees

http://www.azzur.com

H1B Sponsorship

Azzur Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (62)

2021 (1)

2020 (1)