Sr Manager, Process Development & TT

Job summary

Lead the technology transfer of products and platforms into the cGMP environment and manage a results-driven team for process monitoring and trend analysis. Collaborate with manufacturing operations to drive process improvements, troubleshoot processing issues, and ensure regulatory compliance.

Job details

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions tocommunities 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 Senior 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 the oversight of tech transfers from R&D / Product Development and client contracts and hold department accountable for completion. 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. Offer department subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions and validation protocols. 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 10 years of relevant experience. At least 10 years of prior supervisory experience required. At least 5 years of prior floor experience in pharmaceutical manufacturing operations. Proven track record of management and leadership effectiveness. Advanced knowledge of CGMP, LEAN manufacturing & operational excellence. Strong understanding of data trending & statistical analysis. 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.

What you’ll do

Lead the technology transfer of products and platforms into the cGMP environment and manage a results-driven team for process monitoring and trend analysis. Collaborate with manufacturing operations to drive process improvements, troubleshoot processing issues, and ensure regulatory compliance.

Requirements

Requires a Bachelor's degree in Engineering, Microbiology, Biochemistry, or a related science with at least 10 years of relevant and supervisory experience. Must have at least 5 years of experience in pharmaceutical manufacturing operations and advanced knowledge of CGMP and Lean manufacturing.

Benefits

• Competitive Salaries
• Flexible Work Arrangements
• Extensive Benefits Package

Listed skills

• Process Optimization · Preferred
• Operational Excellence · Preferred
• Lean Manufacturing · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Technology Transfer
• Process Development
• cGMP
• Lean Manufacturing
• Operational Excellence
• Data Trending
• Statistical Analysis
• Process Optimization
• Risk Assessment
• Project Management
• People Management
• Validation Protocols

Job areas

• Manufacturing
• Management & Leadership
• Science & Research
• Engineering
• Healthcare

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