Molecular Biologist San Diego, CA, United States **Job Summary** Under our Diagnostics division's Manufacturing Operations group, the Molecular Biologist is responsible for the manufacture of bulk clinical and commercial kit reagents and for sub-assembly formulation, raw material prep and/or processing. Actively participate in transfer and support activities and continuous improvement on the existing processes. May be assigned to one or more functional areas in Operations. This is a fully onsite position based out of our San Diego, CA campus. **Essential Duties and Responsibilities** + Oversees and leads the daily operation activities of the BSL2/BLS3 laboratories. + Creates weekly production schedule including product support and transfer activities. + Able to perform 80% of mfg. activities in Production Microbiology and TPZ departments. + Provides and tracks department training. + Attends weekly production planning, support and transfer meetings, as required. + Writes monthly production reports. + Originates moderate to complex ECO/SCOs with no assistance. + Perform/execute complex NCE Investigations, implementing and training others on root cause analysis and test plan tools + May represent group at MRB. + Creates/revises production task lists and BOM lists to support Operations. + May reviews manufacturing documentation, including development and notebook studies for operations. + Participates in FDA, ISO lab audits and performs BSL3 audits. + May represent group as extended core team member on one or more core teams or on other teams. + Interfaces with R&D to learn new process and transfers knowledge to department. Reviews and approves process transfer reports, as required. + Performs feasibility studies and assists in creating project plans. + Participates in Continuous Improvement from inception to completion. + Cross-train in other areas of mfg. & operations. + Oversees the execution of validation protocols for mfg. equipment and generates reports. + May perform ECO assessments. + Performs doc. owner activities for department. **Required Education and Qualifications** + Bachelor's of Science in Cell Biology, Molecular Biology or relevant field, with a minimum of 3-5 years of related experience, ideally in GMP/GDP/GLP environment + Knowledge of Microbiology/Molecular and Chemistry. + Working knowledge of laboratory safety and record keeping. + Strong mathematics skills. + Knowledge of ERP. + Knowledge of GMP/GLP, ISO and CDC Safety Regulations Blood Borne Pathogen Training **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role. From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more. The annualized base salary range for this role is $69,000 - $100,500 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.** \#LI-RF1 #onsite #mid-level