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Hologic Manager, Process Development Engineering - Sustaining in San Diego, California

Manager, Process Development Engineering - Sustaining

San Diego, CA, United States

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, 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 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 achieve 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 / 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 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 process, as applicable

  • Familiarity with Lateral Flow assays is desirable

The annualized base salary range for this role is $117,900 to $196,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency And Third Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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