Hologic Production Chemist IV (TPZ Lead) in San Diego, California

Production Chemist IV (TPZ Lead)

Post Date 5 days ago

This position is for the Lead Production Chemist in TPZ Manufacturing . The selected candidate is expected to be a leader in safety, quality, and continuous improvement within the TPZ team. He or she will be responsible for a wide variety of tasks such as tracking metrics, production scheduling, nonconformance investigation, batch record review, bulk formulation, and training of department personnel.

Duties & Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Drive a culture of safety, quality and continuous improvement on the manufacturing floor

  • Develop and maintain the weekly production schedule to optimize production efficiency

  • Execute bulk formulation, reagent filling, and other lab activities

  • Review and approve manufacturing batch records

  • Act as a technical expert for the manufacturing area

  • Resolve minor issues ensuring production schedule is on track

  • Monitor and update production metrics

  • Perform NCR and customer complaint investigations

  • Assist with internal and external audits

  • Lead and monitor training of department personnel

  • Perform Lab audits for cGMP and safety compliance

  • Audit and sustaining 6S in manufacturing suites

  • Cycle count entry, variance investigation and justification write-up

  • Implement Continuous Improvement and cost saving ideas

  • Provide weekly Hot Topics in absence of the Supervisor

  • Identify and implement SOP/Mfg batch record improvements

  • Review, monitor, and edit production routings as needed for accuracy

  • Coordinate with Quality Micro for EM requirements

  • Monitor scheduled Analyte Changeovers and request timely QA Room Releases

  • Assist with process transfers and development manufacturing

  • Schedule and coordinate vendor activities

  • iProcurement orders (CCS POs, Orbis, VWR, MSC, general lab supplies)

  • Review and approve ECOs and SCOs

  • Ensure lab supplies and non-inventory items are available and replenished as needed

  • Responsible for CAPA/Task completion, tracking, date extensions, audit findings, etc.

  • Create PDVs and product Test Plans as needed

  • Act as point of contact for 2 nd shift employees in TPZ

  • Provide training to the manufacturing team

  • Generate Facility Service Requests and Change Controls

  • Coordinate lab shutdown activities to prevent production disruption

  • Perform backup activities for Supervisor and other duties as needed


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

  • Collaboration

  • Interpersonal skills

  • Leadership skills

  • Organizational skills

  • Training skills

  • Analytical

  • Technical skills

  • Team Orientation

  • Presentation

  • Advanced GMP and safety knowledge.

  • Understanding of Planning function

  • Strong technical understanding and experience in one or more manufacturing areas.

  • Document owner for department.

  • Good presentation skills

  • Technical writing skills


  • Typically requires BA or BS


  • Typically a minimum of 2-5 years related experience

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.