Senior Manager of Microbiology and Sterility Assurance

4 weeks ago

Raleigh, United States BioTalent Full time

Senior Manager, Microbiology & Sterility Assurance – North Carolina – Competitive Package

I am representing an established, global health care provider who is on the search for a Sterility Assurance Director. You will be responsible for leading and overseeing a Microbiology team across key laboratory activities and projects.

This role will offer you:

A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives. A lot of mobility and autonomy in the role, while working with a strong leadership team. The scope to develop and establish the sterility assurance program for state-of-the-art manufacturing facilities ensuring excellent compliance Competitive salary, stock purchase program, Tuition reimbursement, PTO, 401k match, Medical/Dental/Vision coverage

You will be responsible for:

Develop and implement sterility assurance and microbiology strategies, policies, and procedures for the company's manufacturing facilities. Leading the implantation of quality systems procedures and handling compliance across the department Overseeing and managing microbiology laboratory activities - environmental monitoring, microbiology testing, microbial identification Leading and managing a team of sterility assurance and microbiology professionals Participate in regulatory inspections and lead the quality assessment of internal operations & suppliers to assess any risks Responsible for the strategy to ensure and improve clean room controls with the facility to minimize risk and cross-contamination

Desirable experience and qualifications:

Significant experience with microbiology, sterility assurance, aseptic processing within pharmaceutical/biotech manufacturing BS degree in Science, concentration in Biology or Microbiology, preferably Proven experience managing and leading teams Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing Experience with regulatory inspections and audits

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