Hologic, Inc.
Manager, Process Development Engineering - Sustaining
Hologic, Inc., San Diego, California, United States, 92189
As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.Our Operations team sits at the core of what we do as a business, combining process development, supply chain, manufacturing, and quality control. From improving quality, reducing costs, and increasing throughput, our Operations team enables us to meet and exceed our customer expectations and driving us to be the best.The
Manager, Process Development Engineering - Sustaining
will be responsible for a team focused on the creation, validation, and maintenance/troubleshooting of manufacturing processes used in Hologic’s Molecular Diagnostic and Lateral Flow commercialized products. By working cross-functionally, this individual will assist the Operations organization in achieving product availability, business continuity, and VIP goals.Essential Duties and Responsibilities:Sustain and improve the core business by implementing technical and business processes.Assess manufacturing operations and implement process improvements including but not limited to scale-ups, scale-downs, raw material changes, automation, and VIPs.Lead discussions to assess right-sizing the manufacturing operations by proactively walking the floor, conducting technical/business reviews, and auditing routings.Define process validation/raw material qualification strategies and lead NCE and CAPA investigations.Demonstrate and promote a culture of continuous improvement by implementing LEAN and Six Sigma methodologies.Lead and develop a team of process engineers, scientists, and associates.Education:BS, MS, or PhD in Biotechnology, Biochemical Engineering, or a related field.Experience:8-10+ years’ experience in an IVD or pharmaceutical GMP manufacturing environment.5+ years’ experience in leading and developing technical teams.Skills/Knowledge:Experience with all aspects of NAAT manufacturing such as oligonucleotide synthesis, bulking, filling, lyophilization, packaging, and shipping with manual, semi-automated, and automated processes, as applicable.Familiarity with Lateral Flow assays is desirable.
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Manager, Process Development Engineering - Sustaining
will be responsible for a team focused on the creation, validation, and maintenance/troubleshooting of manufacturing processes used in Hologic’s Molecular Diagnostic and Lateral Flow commercialized products. By working cross-functionally, this individual will assist the Operations organization in achieving product availability, business continuity, and VIP goals.Essential Duties and Responsibilities:Sustain and improve the core business by implementing technical and business processes.Assess manufacturing operations and implement process improvements including but not limited to scale-ups, scale-downs, raw material changes, automation, and VIPs.Lead discussions to assess right-sizing the manufacturing operations by proactively walking the floor, conducting technical/business reviews, and auditing routings.Define process validation/raw material qualification strategies and lead NCE and CAPA investigations.Demonstrate and promote a culture of continuous improvement by implementing LEAN and Six Sigma methodologies.Lead and develop a team of process engineers, scientists, and associates.Education:BS, MS, or PhD in Biotechnology, Biochemical Engineering, or a related field.Experience:8-10+ years’ experience in an IVD or pharmaceutical GMP manufacturing environment.5+ years’ experience in leading and developing technical teams.Skills/Knowledge:Experience with all aspects of NAAT manufacturing such as oligonucleotide synthesis, bulking, filling, lyophilization, packaging, and shipping with manual, semi-automated, and automated processes, as applicable.Familiarity with Lateral Flow assays is desirable.
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