Manager, Process Development & TT

Emergent Biosolutions; Winnipeg; On-site; CAD 90,000 - 130,000; Full time

Job summary

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.

Responsibilities

• 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

Skills

People leadership

CGMP knowledge

Process development

Technology transfer

Data trending

Root cause analysis

Continuous improvement

Education

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

Job description

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Emergent is a leading public health company that delivers protective and life‑saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary

Reporting to the Director of MSAT, the Manager of Process Development / Technology Transfer will play a critical role in the long-term success of the Winnipeg site. The incumbent will develop a strong, results‑driven team responsible for the tech transfer of products and platforms into the cGMP environment, the monitoring and trend analysis of product and platform performance, technical support for the licensed products manufactured at the site and collaborate around technology enhancements and process improvements within Emergent Winnipeg.

Responsibilities

• 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

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• 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.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.