Preparedness today, safer tomorrow. 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 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 <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Manage the oversight of tech transfers from R&D / Product Development and client contracts and hold department accountable for completion.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Work in collaboration with manufacturing operations leaders to ensure alignment on problem solving and process improvement</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Build strong relationships with Manufacturing operations to ensure alignment on daily priorities & deliverables.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Offer department subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions and validation protocols. </li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Oversee the design, development, execution, and analysis of evaluation studies to troubleshoot processing issues, or generate data to support a process improvement.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Lead process optimization initiatives for existing manufacturing processes to reduce variability or increase profitability.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Manage the process monitoring & trending program to ensure risks are identified early and responded to proactively.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Coordinate studies and reports relating to process understandings, system capabilities and equipment performance through partnership with production, Engineering and Validation </li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Coordinate process risk assessments for tech transfers to evaluate impacts of new product process implementation.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Lead team effectively within quality systems to drive quality outputs and efficient project execution </li> </ul> 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 <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Bachelor’s Degree in Engineering, Microbiology, Biochemistry, or closely related scientific discipline would be an asset, with at least 10 years of relevant experience.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">At least 10 years of prior supervisory experience required.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">At least 5 years of prior floor experience in pharmaceutical manufacturing operations.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Proven track record of management and leadership effectiveness. </li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Advanced knowledge of CGMP, LEAN manufacturing & operational excellence.</li> <li style="line-height:150%;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Strong understanding of data trending & statistical analysis.</li> </ul>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 <a href="http://ebsi.com/?q=node/138">Privacy Policy</a>.

Sr Manager, Process Development & TT (Winnipeg, MB, CA, R3T 5Y3) @ Emergent Biosolutions

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