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Sr. Manager, Sterility Assurance

Company: Renaissance LLC
Location: Lakewood
Posted on: January 15, 2021

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Overview

The Sr. Manager, Sterility Assurance is responsible for the overall performance of the sterility assurance group and its functions. The purpose of this position is to lead a group of scientific personnel in the execution and timely completion of projects. The position is expected to use their knowledge and skills to mentor/advise less experienced members within the group. The individual will manage the sterility assurance group and ensure compliance with all regulatory guidance, Renaissance procedures and good documentation practices. The individual is responsible for being the SME for all related procedures pertaining to sterility assurance and aseptic manufacturing. This includes but is not limited to Media Challenges, Smoke studies, Sterilization, Aseptic Manipulations, Clean room management. Gown Training, and Clean room behavior. Responsibilities may also include interviewing, hiring, training employees, planning, assigning, and directing work; appraising performance, rewarding and disciplining personnel, addressing complaints and resolving issues.

This position may also interact frequently with regulatory/compliance personnel at Renaissance Lakewood, LLC. It will assure compliance to all FDA and international regulations with regard to sterility assurance activities. The employee in this role must be able to represent Renaissance with customers and senior management.


  • Provide technical expertise and understanding on the qualification and requalification approach surrounding media fills, dose audits, EMPQ, and sterilization activities.
  • Develop Design of Experiments (DOEs), develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
  • Review and approval of documents including, Sterilization, Dose Audit Reports, Impact Assessments, and Media Fill Records/SIP/FIT.
  • Implementation of applicable regulatory requirements and guidance ensuring compliance with FDA, ISO, EMA and any other applicable domestic and international regulations and / or guidance documents.
  • Schedule, plan, manage, and deploy resources to support sterility assurance activities and efforts, as needed, to ensure Renaissance and customer timelines are met.
  • Provide technical assistance for investigations into process/product issues in support of sterility, media fill, EMPQ and dose audit deviations and review of design requirements for aseptic products and or equipment.
  • Interface with customers on transfer discussions, timelines, project deliverables, etc.
  • Effectively manage personal activities and manage the timeliness of the team as well as participate and/or lead/manage project related team activities. The candidate must be able to report project status and team performance capability to cross functional team members and site leadership.
  • Generate and maintain the container closure integrity, environmental monitoring auditing, dose auditing and aseptic media process simulation program plans including incubation requirements and available space.
  • Manage the site Media Challenge program.
  • Manage the site Smoke Studies program.


  • Bachelor of Science degree in a Science, Engineering or other related field required. Advanced education is preferred.
  • Minimum of five (5) years' relevant experience performing in an aseptic pharmaceutical environment is required.
  • Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH. Examples of successfully interacting with the FDA and governing bodies
  • At least 3+ years of leadership experience with direct reports mentoring teams
  • Must have experience with qualification for EMPQ, media fill, dose audits, aseptic manipulations, clean room management and/or sterilization activities
  • Demonstrate examples utilizing DOE and statistical sampling plans to identify, assess and implement quality changes
  • Demonstrate examples of dealing with customers; fixing an issue, meeting & managing project timelines and/or managing technology transfer activities
    Strong problem-solver with emotional maturity and servant leadership mentality PI127909857

Keywords: Renaissance LLC, Lakewood , Sr. Manager, Sterility Assurance, Executive , Lakewood, New Jersey

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