Lead, Process Development & Tech Transfer

Emergent BioSolutions, Inc.; Winnipeg; Sur place; CAD 90 000 - 130 000; Plein temps

Résumé du poste

Emergent BioSolutions, Inc. Winnipeg site seeks a Manager of Process Development / Technology Transfer to lead tech transfer from R&D to cGMP operations, drive process optimization, and ensure timely delivery of project milestones.

You will build and mentor a results-oriented team, collaborate with Manufacturing, Quality and Validation, and apply data trending and continuous improvement methodologies to reduce variability and enhance product performance.

Qualifications

• Bachelor’s Degree in Engineering, Microbiology, Biochemistry, or closely related scientific discipline would be an asset, with at least 7 - 10 years of relevant experience.
• At least 3 - 5 years of people leadership experience.
• Proven track record of management and leadership effectiveness.
• Strong knowledge of CGMP, process development, and technology transfer.
• Experience with data trending, root cause analysis, and continuous improvement methodologies.

Responsabilités

• Manage technology transfer activities from R&D / Product Development and client contracts, ensuring project deliverables are completed on schedule.
• Work in collaboration with manufacturing operations leaders to ensure alignment on problem solving and process improvement.
• Build strong relationships with Manufacturing operations to ensure alignment on daily priorities & deliverables.
• Provide technical expertise as a reviewer of project plans, technical reports and regulatory submissions.
• Oversee the design, development, execution, and analysis of evaluation studies to troubleshoot processing issues, or generate data to support a process improvement.
• Lead process optimization initiatives for existing manufacturing processes to reduce variability or increase profitability.
• Manage the process monitoring & trending program to ensure risks are identified early and responded to proactively.
• Coordinate studies and reports relating to process understandings, system capabilities and equipment performance through partnership with Production, Engineering and Validation
• Coordinate process risk assessments for tech transfers to evaluate impacts of new product process implementation.
• Lead team effectively within quality systems to drive quality outputs and efficient project execution

Connaissances

People leadership

CGMP knowledge

Process development

Technology transfer

Data trending

Root cause analysis

Continuous improvement

Formation

Bachelor’s degree in Engineering, Microbiology, Biochemistry

Experience: 7-10 years

People leadership experience 3-5 years

Management and leadership track record

CGMP/process development/tech transfer knowledge

Description du poste

Emergent BioSolutions, Inc. Winnipeg site seeks a Manager of Process Development / Technology Transfer to lead tech transfer from R&D to cGMP operations, drive process optimization, and ensure timely delivery of project milestones.

You will build and mentor a results-oriented team, collaborate with Manufacturing, Quality and Validation, and apply data trending and continuous improvement methodologies to reduce variability and enhance product performance.