Molecular Biologist

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.

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