Director, Microbiology

Employer
Glaukos Corporation
Location
San Clemente, California, US
Salary
Competitive
Posted
Jul 22, 2021
Closes
Aug 02, 2021
Ref
2333192112
Discipline
Biology, Finance
Employment Type
Full time
Salary Type
Salary
How will you make an impact?

Based in San Clemente, CA the Director, Microbiology within Glaukos' Pharmaceutical Research and Development provides technical leadership to internal project teams and outside CROs to develop appropriate manufacturing processes for minimal bioburden and sterility assurance, and regulatory compliant bioburden and sterility testing methods required to support Glaukos' sterile ophthalmic product research and development. This individual will also oversee microbiology external contractors/vendors, including vendor selection, method development, qualification, and validation activities to support research and early clinical development of ophthalmic drug products. He/She will also participate in drug development project teams to define appropriate microbiology product specifications and acceptance criteria.

What will you do?
  • Acts as an internal consultant to teams working on in-process bioburden control and as a subject matter expert for sterilization method and bioburden and sterility test methods development.
  • Responsible for providing technical expertise, oversight, and testing to support new product development, regulatory submissions, sustaining projects, and release of commercial products.
  • Serves as Glaukos' key Subject Matter Expert on microbiology and physical testing, method development and sterilization process validation, and regulatory compliance requirements for pharmaceutical manufacturing.
  • Provides technical and tactical support for the Glaukos research and development project teams to ensure compliance with cGMP and regulatory requirements for sterile ophthalmic drug products both internally and externally.
  • Interact with FDA and other regulatory authorities as Subject Matter Expert for Quality Microbiology processes, procedures and analytical test methods.
  • This role also collaborates with internal functions (e.g. other functions in R&D, cGMP Quality Control Laboratory, Operations, Legal, HR, Finance, IT) to execute the activities and ensure alignment with Glaukos procedures.
  • Oversees the transfer of the microbiology test methods for validation to the cGMP QC testing laboratory.
  • Drives development of advanced technologies, principles, and processes.
  • Ensures budgets, schedules, and performance requirements are met.
  • Author/review of regulatory filing sections/correspondence.
  • Resource and budget planning for the microbiology and sterilization studies.

How will you get here?

Education:
  • BS in Chemistry, Pharmacy, Biology or a related pharmaceutical science.
  • MS or PhD in Chemistry is preferred.

Requirements:
  • 12+ years of progressive managerial experience within the Microbiology function of a pharmaceutical company.
  • In-depth experience in microbiology test method development are required.
  • Judgement is required in resolving complex problems based on experience, especially in highly innovative novel product space that may require unprecedented, novel sterility assurance approaches due to micro-sized drug delivery devices/implants.
  • Extensive knowledge and experience in GXP and QA principles, practices & industry standards in the microbiology area.
  • A strong team player is required with the ability to effectively communicate cross-functionally based on experience, regulations & business needs.
  • Excellent technical writing, presentation and oral/written communication skills with using risk-based principles & decision making to ensure compliance at all stages of development.
  • Proven track-record of leadership & building relationships with both internal & external customers.
  • Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.